Trial Outcomes & Findings for Effects of Vitamin D and Omega-3 on Cerebrovascular Disease (NCT NCT04070833)
NCT ID: NCT04070833
Last Updated: 2022-08-15
Results Overview
modified Rankin Scale (mRS) at hospital discharge The mRS is often seen as a measure of disability or a "global health index" due to its strong emphasis on mobility although it claims to be a measure of handicap. The mRS is a seven-point scale (0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death). To avoid issues with model convergence due to sparse data, I will a priori categorize the mRS into good (mRS 0-2) versus poor (mRS 3-6) outcomes. These data were collected during the parent study (NCT01169259)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
1 day
Results posted on
2022-08-15
Participant Flow
This study only enrolled individuals from the main VITAL study who experienced a stroke during the main VITAL study. Therefore, although the main VITAL study enrolled 25871 individuals, the current study only includes the 290 individuals who experienced a stroke event during the main VITAL study.
Participant milestones
| Measure |
Vitamin D + Fish Oil
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\])
|
Vitamin D + Fish Oil Placebo
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo
|
Vitamin D Placebo + Fish Oil
Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\]) Vitamin D placebo: Vitamin D placebo
|
Vitamin D Placebo + Fish Oil Placebo
Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
75
|
82
|
67
|
|
Overall Study
COMPLETED
|
58
|
69
|
71
|
60
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
Baseline characteristics by cohort
| Measure |
Vitamin D + Fish Oil
n=66 Participants
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol
Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\])
|
Vitamin D + Fish Oil Placebo
n=75 Participants
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol
Fish oil placebo: Fish oil placebo
|
Vitamin D Placebo + Fish Oil
n=82 Participants
Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\])
Vitamin D placebo: Vitamin D placebo
|
Vitamin D Placebo + Fish Oil Placebo
n=67 Participants
Vitamin D placebo: Vitamin D placebo
Fish oil placebo: Fish oil placebo
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
71.6 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
72.0 years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic white
|
46 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Non-African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Functional limitation at baseline
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because the mRS was missing for some participants.
modified Rankin Scale (mRS) at hospital discharge The mRS is often seen as a measure of disability or a "global health index" due to its strong emphasis on mobility although it claims to be a measure of handicap. The mRS is a seven-point scale (0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death). To avoid issues with model convergence due to sparse data, I will a priori categorize the mRS into good (mRS 0-2) versus poor (mRS 3-6) outcomes. These data were collected during the parent study (NCT01169259)
Outcome measures
| Measure |
Active Vitamin D
n=127 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=131 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=129 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=129 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)
Good outcome (mRS 0-2)
|
84 Participants
|
99 Participants
|
96 Participants
|
87 Participants
|
|
Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)
Poor outcome (mRS 3-6)
|
43 Participants
|
32 Participants
|
33 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors.
Functional limitations will be assessed through self-report using the physical performance scale adapted from Nagi. The adapted Nagi scale asks respondents if they experience any limitations in each of the following items: pulling or pushing large objects; stooping, crouching, or kneeling; reaching or extending arms above shoulder level; reaching or extending arms below shoulder level; writing or handling or fingering small objects; standing in one place for long periods; and sitting for an hour. Participants reporting a limitation in any of these items will be considered to have at least one functional limitation after stroke.
Outcome measures
| Measure |
Active Vitamin D
n=93 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=104 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=99 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=98 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi
|
24 Participants
|
27 Participants
|
20 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors.
The modified Katz ADL scale ask participants to self-report if they need needing help with any of the following items: bathing; dressing; eating; getting in and out of a chair; and walking 50 yards. Individuals who report needing help with any of those items will be considered to have a physical disability after stroke.
Outcome measures
| Measure |
Active Vitamin D
n=93 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=104 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=99 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=98 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale
|
6 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors.
The Rosow-Breslau Functional Health Scale asks participants to self-report if they need help with any of the following tasks: walking 0.5 mile; walking up and down stairs to the second floor; and doing heavy work around the house. Individuals who report needing help with any of those tasks will be considered to have a physical disability after stroke.
Outcome measures
| Measure |
Active Vitamin D
n=93 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=104 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=99 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=98 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale
|
45 Participants
|
53 Participants
|
42 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors.
Social disability was assessed through a self-administered questionnaire which asked questions about social functioning developed in the Framingham Heart Study. The scale covers five social areas (housekeeping, transportation, social interaction, food preparation, and grocery shopping). Respondents are grouped into four categories (need met, no apparent problem (best outcome); need met, potential problem; uncertain need met, potential problem; need unmet, current problem (worst outcome)) for each social area using a previously published algorithm. We created summary indices for the total number of unmet needs across all areas and for the total number of unmet needs or uncertain needs met, potential problem. These indices range from 0 to 5, but to avoid problems with model convergence due to sparse data, we will a priori categorize them as 0 (best outcome), 1, or ≥2 (worst outcome).
Outcome measures
| Measure |
Active Vitamin D
n=94 Participants
Vitamin D3, one 2000 IU capsule/day
|
Vitamin D Placebo
n=105 Participants
Vitamin D placebo, one capsule/day
|
Active Omega-3 Fatty Acids
n=99 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=100 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Unmet need · 0
|
81 Participants
|
98 Participants
|
92 Participants
|
87 Participants
|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Unmet need · 1
|
10 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Unmet need · 2
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Uncertain need met or unmet need · 0
|
59 Participants
|
79 Participants
|
74 Participants
|
64 Participants
|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Uncertain need met or unmet need · 1
|
19 Participants
|
16 Participants
|
13 Participants
|
22 Participants
|
|
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Uncertain need met or unmet need · 2
|
16 Participants
|
10 Participants
|
12 Participants
|
14 Participants
|
Adverse Events
Vitamin D + Fish Oil
Serious events: 18 serious events
Other events: 16 other events
Deaths: 7 deaths
Vitamin D + Fish Oil Placebo
Serious events: 20 serious events
Other events: 16 other events
Deaths: 4 deaths
Vitamin D Placebo + Fish Oil
Serious events: 28 serious events
Other events: 17 other events
Deaths: 7 deaths
Vitamin D Placebo + Fish Oil Placebo
Serious events: 19 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Vitamin D + Fish Oil
n=66 participants at risk
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\])
|
Vitamin D + Fish Oil Placebo
n=75 participants at risk
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo
|
Vitamin D Placebo + Fish Oil
n=82 participants at risk
Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\]) Vitamin D placebo: Vitamin D placebo
|
Vitamin D Placebo + Fish Oil Placebo
n=67 participants at risk
Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
1/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
1/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
1/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, 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)
Malignant Cancer
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.7%
3/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
1/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Cardiac disorders
Major CVD
|
27.3%
18/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
25.3%
19/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
30.5%
25/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
23.9%
16/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
Other adverse events
| Measure |
Vitamin D + Fish Oil
n=66 participants at risk
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\])
|
Vitamin D + Fish Oil Placebo
n=75 participants at risk
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo
|
Vitamin D Placebo + Fish Oil
n=82 participants at risk
Fish oil: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per 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 \[DHA\]) Vitamin D placebo: Vitamin D placebo
|
Vitamin D Placebo + Fish Oil Placebo
n=67 participants at risk
Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Easy bruising
|
6.1%
4/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
8.0%
6/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.7%
3/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
9.0%
6/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Blood and lymphatic system disorders
Frequent nosebleeds
|
3.0%
2/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.7%
2/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.4%
2/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, 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
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
1/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Endocrine disorders
Parathyroid condition
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
1/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Renal and urinary disorders
Kidney stones
|
3.0%
2/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
1/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
1/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, 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
|
1.5%
1/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Stomach upset or pain
|
3.0%
2/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
4.0%
3/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.4%
2/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.5%
1/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.5%
3/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.7%
2/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.1%
5/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.7%
3/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.0%
4/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Constipation
|
6.1%
4/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
5.3%
4/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
1/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
1/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.2%
1/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
6.0%
4/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
General disorders
Bad taste in mouth
|
0.00%
0/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
0.00%
0/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.4%
2/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
|
Gastrointestinal disorders
Increased burping
|
3.0%
2/66 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
1.3%
1/75 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
2.4%
2/82 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
3.0%
2/67 • Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place