Trial Outcomes & Findings for Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (NCT NCT00436475)
NCT ID: NCT00436475
Last Updated: 2019-07-30
Results Overview
Range is 0 to infinity Lower is better.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
92 participants
Primary outcome timeframe
baseline and 4 months
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Vitamin D-Calcium
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
Vitamin D3-Placebo plus Calcium-Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
22
|
24
|
|
Overall Study
COMPLETED
|
23
|
22
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Vitamin D-Calcium
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
n=22 Participants
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
n=24 Participants
Vitamin D3-Placebo plus Calcium-Placebo
|
Total
n=92 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
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Age, Categorical
>=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, Continuous
|
57 years
STANDARD_DEVIATION 2 • n=5 Participants
|
57 years
STANDARD_DEVIATION 2 • n=7 Participants
|
57 years
STANDARD_DEVIATION 2 • n=5 Participants
|
59 years
STANDARD_DEVIATION 2 • n=4 Participants
|
57 years
STANDARD_DEVIATION 1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 monthsRange is 0 to infinity Lower is better.
Outcome measures
| Measure |
Vitamin D-Calcium
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
n=21 Participants
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
n=22 Participants
Vitamin D3-Placebo plus Calcium-Placebo
|
|---|---|---|---|---|
|
Chang in Disposition Index, a Measure of Beta Cell Function
|
287 units on a scale
Standard Error 170
|
314 units on a scale
Standard Error 183
|
-122 units on a scale
Standard Error 177
|
-129 units on a scale
Standard Error 174
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsThis outcome measures change in Hemoglobin A1c, a measure of glycemia
Outcome measures
| Measure |
Vitamin D-Calcium
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
n=23 Participants
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
n=22 Participants
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
n=24 Participants
Vitamin D3-Placebo plus Calcium-Placebo
|
|---|---|---|---|---|
|
Change in Hemoglobin A1c
|
0.05 % of hemoglobin
Standard Error 0.05
|
0.08 % of hemoglobin
Standard Error 0.05
|
0.09 % of hemoglobin
Standard Error 0.05
|
0.18 % of hemoglobin
Standard Error 0.04
|
Adverse Events
Vitamin D-Calcium
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Vitamin D Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Calcium Only
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo-Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D-Calcium
n=23 participants at risk
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
n=23 participants at risk
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
n=22 participants at risk
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
n=24 participants at risk
Vitamin D3-Placebo plus Calcium-Placebo
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
4.3%
1/23
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
Other adverse events
| Measure |
Vitamin D-Calcium
n=23 participants at risk
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
Vitamin D Only
n=23 participants at risk
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Calcium Only
n=22 participants at risk
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Placebo-Placebo
n=24 participants at risk
Vitamin D3-Placebo plus Calcium-Placebo
|
|---|---|---|---|---|
|
General disorders
Pain
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
|
General disorders
Injury
|
4.3%
1/23
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
4.3%
1/23
|
0.00%
0/23
|
9.1%
2/22
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
13.0%
3/23
|
8.7%
2/23
|
4.5%
1/22
|
0.00%
0/24
|
|
Renal and urinary disorders
UTI
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
|
Eye disorders
Eye irritation
|
0.00%
0/23
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
|
General disorders
Other
|
0.00%
0/23
|
0.00%
0/23
|
9.1%
2/22
|
8.3%
2/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place