Trial Outcomes & Findings for Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure (NCT NCT02271230)
NCT ID: NCT02271230
Last Updated: 2022-03-18
Results Overview
We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25871 participants
Primary outcome timeframe
5 years
Results posted on
2022-03-18
Participant Flow
A total of 401605 adults were initially screened; 39430 eligible to enter run-in; 25871 eligible for randomization; 2x2 factorial design: 12927 assigned to active vit D (of these, 6463 were assigned to active omega-3 FAs and 6464 to placebo omega-3 FAs) \& 12944 assigned to placebo vit D (of these, 6470 were assigned to active omega-3 FAs and 6474 to placebo omega-3 FAs)
The trial included a 3-month placebo run-in period to select participants likely to have excellent compliance. Only individuals who reported taking at least 2/3 of their study pills during the run-in and met other eligibility criteria were randomized into the trial.
Participant milestones
| Measure |
Active Vitamin D + Active Omega-3 Fatty Acids
Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Active Vitamin D + Placebo Omega-3 Fatty Acids
Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
|
Placebo Vitamin D + Active Omega-3 Fatty Acids
Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Placebo Vitamin D + Placebo Omega-3 Fatty Acids
Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6463
|
6464
|
6470
|
6474
|
|
Overall Study
COMPLETED
|
6463
|
6464
|
6470
|
6474
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
Baseline characteristics by cohort
| Measure |
Active Vitamin D + Active Omega-3 Fatty Acids
n=6463 Participants
Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Active Vitamin D + Placebo Omega-3 Fatty Acids
n=6464 Participants
Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
|
Placebo Vitamin D + Active Omega-3 Fatty Acids
n=6470 Participants
Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
Placebo Vitamin D + Placebo Omega-3 Fatty Acids
n=6474 Participants
Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day
|
Total
n=25871 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 7.1 • n=6463 Participants
|
67.1 years
STANDARD_DEVIATION 7.0 • n=6464 Participants
|
67.2 years
STANDARD_DEVIATION 7.1 • n=6470 Participants
|
67.1 years
STANDARD_DEVIATION 7.1 • n=6474 Participants
|
67.1 years
STANDARD_DEVIATION 7.1 • n=25871 Participants
|
|
Sex: Female, Male
Female
|
3276 Participants
n=6463 Participants
|
3271 Participants
n=6464 Participants
|
3271 Participants
n=6470 Participants
|
3267 Participants
n=6474 Participants
|
13085 Participants
n=25871 Participants
|
|
Sex: Female, Male
Male
|
3187 Participants
n=6463 Participants
|
3193 Participants
n=6464 Participants
|
3199 Participants
n=6470 Participants
|
3207 Participants
n=6474 Participants
|
12786 Participants
n=25871 Participants
|
|
Race/Ethnicity, Customized
count · Non-Hispanic White
|
4515 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
4498 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
4529 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
4504 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
18046 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Race/Ethnicity, Customized
count · African American
|
1278 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
1275 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
1271 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
1282 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
5106 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Race/Ethnicity, Customized
count · Hispanic (not African American)
|
246 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
270 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
245 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
252 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
1013 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Race/Ethnicity, Customized
count · Asian/Pacific Islander
|
102 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
86 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
98 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
102 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
388 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Race/Ethnicity, Customized
count · Native American/Alaskan Native
|
62 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
56 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
58 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
52 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
228 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Race/Ethnicity, Customized
count · Other/Unknown
|
126 Participants
n=6329 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
133 Participants
n=6318 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
123 Participants
n=6324 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
141 Participants
n=6333 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
523 Participants
n=25304 Participants • Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled.
|
|
Region of Enrollment
United States
|
6463 participants
n=6463 Participants
|
6464 participants
n=6464 Participants
|
6470 participants
n=6470 Participants
|
6474 participants
n=6474 Participants
|
25871 participants
n=25871 Participants
|
PRIMARY outcome
Timeframe: 5 yearsWe will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.
Outcome measures
| Measure |
Active Vitamin D
n=12904 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=12931 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=12912 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
Omega-3 Fatty Acids Placebo
n=12923 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With New Heart Failure Hospitalization
|
240 Participants
|
259 Participants
|
244 Participants
|
255 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Each participant is allowed to have multiple heart failure hospitalizations.
Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data.
Outcome measures
| Measure |
Active Vitamin D
n=12927 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=12944 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=12933 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
Omega-3 Fatty Acids Placebo
n=12938 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Recurrent Heart Failure Hospitalization
|
341 hospitalizations for heart failure
|
364 hospitalizations for heart failure
|
326 hospitalizations for heart failure
|
379 hospitalizations for heart failure
|
Adverse Events
Active Vitamin D
Serious events: 1673 serious events
Other events: 10086 other events
Deaths: 485 deaths
Vitamin D Placebo
Serious events: 1659 serious events
Other events: 10098 other events
Deaths: 493 deaths
Active Omega-3 Fatty Acids
Serious events: 1613 serious events
Other events: 10094 other events
Deaths: 493 deaths
Omega-3 Fatty Acids Placebo
Serious events: 1619 serious events
Other events: 10090 other events
Deaths: 485 deaths
Serious adverse events
| Measure |
Active Vitamin D
n=12927 participants at risk
Vitamin D3, one capsule of 2,000 IU/day
|
Vitamin D Placebo
n=12944 participants at risk
Vitamin D placebo, 1 capsule/day
|
Active Omega-3 Fatty Acids
n=12933 participants at risk
Omacor, 1 g capsule/day Each capsule of Omacor contains 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA)
|
Omega-3 Fatty Acids Placebo
n=12938 participants at risk
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Gastrointestinal bleeding
|
2.6%
341/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.1%
403/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.9%
370/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.9%
374/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Endocrine disorders
Hypercalcemia
|
1.1%
147/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
143/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
151/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
139/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive cancer of any type
|
6.1%
793/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.4%
824/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.3%
820/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.2%
797/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death from cancer
|
1.2%
154/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.4%
187/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
168/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
173/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in women
|
0.96%
124/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.94%
122/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.90%
117/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.00%
129/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
192/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.7%
219/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.7%
219/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
192/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.39%
51/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.36%
47/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.42%
54/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.34%
44/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Vascular disorders
Major cardiovascular events
|
3.1%
396/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.2%
409/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
386/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.2%
419/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Vascular disorders
Myocardial infarction
|
1.3%
169/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.4%
176/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
145/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
200/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Vascular disorders
Stroke
|
1.1%
141/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
149/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
148/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
142/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Vascular disorders
Death from cardiovascular causes
|
1.2%
152/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
138/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
142/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.1%
148/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
Other adverse events
| Measure |
Active Vitamin D
n=12927 participants at risk
Vitamin D3, one capsule of 2,000 IU/day
|
Vitamin D Placebo
n=12944 participants at risk
Vitamin D placebo, 1 capsule/day
|
Active Omega-3 Fatty Acids
n=12933 participants at risk
Omacor, 1 g capsule/day Each capsule of Omacor contains 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA)
|
Omega-3 Fatty Acids Placebo
n=12938 participants at risk
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Easy bruising
|
26.6%
3434/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
26.3%
3408/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
26.6%
3443/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
26.3%
3399/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Blood and lymphatic system disorders
Frequent nosebleeds
|
3.6%
466/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.8%
490/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.6%
465/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.8%
491/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Blood and lymphatic system disorders
Blood in urine
|
7.0%
911/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.8%
882/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
7.1%
919/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.8%
874/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Endocrine disorders
Parathyroid condition
|
0.39%
50/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.48%
62/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.40%
52/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.46%
60/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Stomach upset or pain
|
37.6%
4860/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
37.6%
4870/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
37.8%
4887/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
37.4%
4843/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Nausea
|
27.2%
3519/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
27.7%
3589/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
27.5%
3558/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
27.4%
3550/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Constipation
|
39.7%
5133/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
39.9%
5162/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
40.1%
5184/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
39.5%
5111/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Diarrhea
|
42.6%
5511/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
43.8%
5668/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
43.3%
5599/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
43.1%
5580/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Increased burping
|
16.8%
2168/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
17.1%
2207/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
17.1%
2217/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
16.7%
2158/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
General disorders
Bad taste in mouth
|
17.0%
2195/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
17.7%
2290/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
17.3%
2240/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
17.4%
2245/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Renal and urinary disorders
Kidney stones
|
3.7%
477/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.3%
426/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.3%
430/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.7%
473/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Renal and urinary disorders
Kidney failure or dialysis
|
0.66%
85/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.68%
88/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.66%
85/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.68%
88/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
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|
Skin and subcutaneous tissue disorders
Skin rash
|
25.3%
3268/12927 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
26.5%
3430/12944 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
25.8%
3331/12933 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
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26.0%
3367/12938 • 5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place