Trial Outcomes & Findings for Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients (NCT NCT01229891)
NCT ID: NCT01229891
Last Updated: 2012-01-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
12-week
Results posted on
2012-01-16
Participant Flow
Participant milestones
| Measure |
Plain Yogurt Drink
daily intake of two bottle (250 mL) plain yogurt drink
|
Vitamin D-fortified Yogurt Drink
daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
|
Vitamin D-calcium Yogurt Drink
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
Baseline characteristics by cohort
| Measure |
Plain Yogurt Drink
n=30 Participants
daily intake of two bottle (250 mL) plain yogurt drink
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
|
Vitamin D-calcium Yogurt Drink
n=30 Participants
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
50.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
25-hydroxyvitamin D
|
50 nmol/L
STANDARD_DEVIATION 26 • n=5 Participants
|
47.5 nmol/L
STANDARD_DEVIATION 27 • n=7 Participants
|
51.3 nmol/L
STANDARD_DEVIATION 43 • n=5 Participants
|
48.8 nmol/L
STANDARD_DEVIATION 38.4 • n=4 Participants
|
|
Fasting serum glucose (FSG)
|
187 mg/dL
STANDARD_DEVIATION 57.1 • n=5 Participants
|
184.1 mg/dL
STANDARD_DEVIATION 63.8 • n=7 Participants
|
184 mg/dL
STANDARD_DEVIATION 57.3 • n=5 Participants
|
185 mg/dL
STANDARD_DEVIATION 58.8 • n=4 Participants
|
|
Insulin
|
7.7 mU/L
STANDARD_DEVIATION 3.2 • n=5 Participants
|
7.7 mU/L
STANDARD_DEVIATION 4.6 • n=7 Participants
|
7.6 mU/L
STANDARD_DEVIATION 4.6 • n=5 Participants
|
7.6 mU/L
STANDARD_DEVIATION 4.1 • n=4 Participants
|
|
HbA1c
|
7.5 percent
STANDARD_DEVIATION 1.5 • n=5 Participants
|
7.4 percent
STANDARD_DEVIATION 1.8 • n=7 Participants
|
7.8 percent
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.6 percent
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
TG
|
160.5 mg/dL
STANDARD_DEVIATION 100.7 • n=5 Participants
|
155.4 mg/dL
STANDARD_DEVIATION 65.9 • n=7 Participants
|
176.6 mg/dL
STANDARD_DEVIATION 91.0 • n=5 Participants
|
164.2 mg/dL
STANDARD_DEVIATION 86.6 • n=4 Participants
|
|
Tchol
|
187.5 mg/dL
STANDARD_DEVIATION 43.3 • n=5 Participants
|
177.5 mg/dL
STANDARD_DEVIATION 41.9 • n=7 Participants
|
187.7 mg/dL
STANDARD_DEVIATION 46.6 • n=5 Participants
|
182.4 mg/dL
STANDARD_DEVIATION 43.8 • n=4 Participants
|
|
LDL
|
88.6 mg/dL
STANDARD_DEVIATION 25.9 • n=5 Participants
|
87.2 mg/dL
STANDARD_DEVIATION 25.1 • n=7 Participants
|
90.2 mg/dL
STANDARD_DEVIATION 27.9 • n=5 Participants
|
88.7 mg/dL
STANDARD_DEVIATION 26.0 • n=4 Participants
|
|
HDL
|
50.8 mg/dL
STANDARD_DEVIATION 8.2 • n=5 Participants
|
46 mg/dL
STANDARD_DEVIATION 9.6 • n=7 Participants
|
47.2 mg/dL
STANDARD_DEVIATION 9.4 • n=5 Participants
|
48 mg/dL
STANDARD_DEVIATION 9.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Serum 25-hydroxyvitamin D
|
45.6 nmol/L
Standard Deviation 45.4
|
76.2 nmol/L
Standard Deviation 28.4
|
78.4 nmol/L
Standard Deviation 40.8
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Fasting Serum Glucose (FSG)
|
203.3 mg/dL
Standard Deviation 64.4
|
171.2 mg/dL
Standard Deviation 59.2
|
174.3 mg/dL
Standard Deviation 50
|
SECONDARY outcome
Timeframe: 12-weekfasting serum insulin concentration
Outcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Insulin
|
10.8 mU/L
Standard Deviation 5.5
|
6.5 mU/L
Standard Deviation 3.3
|
6.4 mU/L
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Hemoglobin A1c (HbA1c)
|
8.7 percent
Standard Deviation 1.4
|
7 percent
Standard Deviation 2.3
|
7.8 percent
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Serum Triglyceride (TG)
|
181.3 mg/dL
Standard Deviation 91.8
|
155.2 mg/dL
Standard Deviation 55.1
|
161.1 mg/dL
Standard Deviation 64.3
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Serum Total Cholesterol (Tchol)
|
197.3 mg/dL
Standard Deviation 48.1
|
182.8 mg/dL
Standard Deviation 43.0
|
178.5 mg/dL
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Serum Low Density Lipoprotein (LDL)
|
93.5 mg/dL
Standard Deviation 24.9
|
91.1 mg/dL
Standard Deviation 19.8
|
96.3 mg/dL
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: 12-weekOutcome measures
| Measure |
Plain Yogurt Drink
n=30 Participants
2 bottle plain yogurt drink per day
|
Vitamin D-fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-fortified yogurt drink per day
|
Vitamin D-calcium Fortified Yogurt Drink
n=30 Participants
2 bottle vitamin D-calcium-fortified yogurt drink per day
|
|---|---|---|---|
|
Serum High Density Lipoprotein (HDL)
|
51.8 mg/dL
Standard Deviation 9.6
|
46.1 mg/dL
Standard Deviation 10
|
48 mg/dL
Standard Deviation 6.8
|
Adverse Events
Plain Yogurt Drink
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D-fortified Yogurt Drink
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin D-calcium Yogurt Drink
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
T Neyestani
National nutrition and food technology institute
Phone: 0982122376471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place