Trial Outcomes & Findings for Optimizing Vitamin D in the Elderly (NCT NCT01554241)
NCT ID: NCT01554241
Last Updated: 2015-02-18
Results Overview
circulating total 25-OH vitamin D concentration
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-02-18
Participant Flow
Following participant consent/enrollment, 4 were ineligible due to clinical instability or abnormal laboratory tests and one withdrew consent.
Participant milestones
| Measure |
Vitamin D3 800 IU/Day
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
24
|
14
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Vitamin D3 800 IU/Day
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
1
|
0
|
|
Overall Study
protocol specified renal stone
|
0
|
0
|
0
|
1
|
|
Overall Study
protocol specified change in eGFR
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Optimizing Vitamin D in the Elderly
Baseline characteristics by cohort
| Measure |
Vitamin D3 800 IU/Day
n=23 Participants
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
n=20 Participants
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
n=24 Participants
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
n=14 Participants
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Age, Continuous
|
84.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
85.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
89.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
90.1 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
87.4 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
24 participants
n=5 Participants
|
14 participants
n=4 Participants
|
81 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 16 weekscirculating total 25-OH vitamin D concentration
Outcome measures
| Measure |
Vitamin D3 800 IU/Day
n=20 Participants
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
n=19 Participants
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
n=20 Participants
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
n=13 Participants
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Total 25-OH Vitamin D3 Level
|
33 ng/mL
Standard Deviation 6
|
34 ng/mL
Standard Deviation 6
|
43 ng/mL
Standard Deviation 10
|
61 ng/mL
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 16 weekscirculating free 25-OH vitamin D3 concentration
Outcome measures
| Measure |
Vitamin D3 800 IU/Day
n=20 Participants
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
n=19 Participants
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
n=20 Participants
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
n=13 Participants
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Free 25-OH Vitamin D3
|
8.7 pg/mL
Standard Deviation 2.1
|
9.5 pg/mL
Standard Deviation 1.7
|
12.2 pg/mL
Standard Deviation 4.3
|
16.8 pg/mL
Standard Deviation 4.3
|
Adverse Events
Vitamin D3 800 IU/Day
Serious events: 7 serious events
Other events: 1 other events
Deaths: 0 deaths
2000 IU/Day D3
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Vitamin D3 4000 IU/Day
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
50,000 IU/Week D3
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D3 800 IU/Day
n=23 participants at risk
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
n=20 participants at risk
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
n=24 participants at risk
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
n=14 participants at risk
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Vascular disorders
serious
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/14 • 16 weeks
|
|
Infections and infestations
flu/pneumonia/sepsis
|
17.4%
4/23 • Number of events 4 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
7.1%
1/14 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
renal complication
|
0.00%
0/23 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
14.3%
2/14 • Number of events 2 • 16 weeks
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/14 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
fall + fracture
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/14 • 16 weeks
|
Other adverse events
| Measure |
Vitamin D3 800 IU/Day
n=23 participants at risk
recommended daily dosage of 800 IU/day D3
vitamin D3 800 IU/day: vitamin D3 800 IU/day
|
2000 IU/Day D3
n=20 participants at risk
D3 2000 IU/day
D3 2000 IU/day: 2000 IU/day D3
|
Vitamin D3 4000 IU/Day
n=24 participants at risk
D3 4000 IU/day
D3 4000 IU/day: vitamin D3 4000 IU/day
|
50,000 IU/Week D3
n=14 participants at risk
D3 50,000 IU weekly
D3 50,000 IU weekly: vitamin D3 50,000 IU/week
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ER visit
|
0.00%
0/23 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/14 • 16 weeks
|
|
Vascular disorders
chest pain
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/14 • 16 weeks
|
Additional Information
Janice B.Schwartz, M.D., Professor of Medicine
University of California, San Francisco
Phone: (415) 406-1573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place