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Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01229891
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition Type 2 Diabetes
Interventions Dietary Supplement: plain yogurt drink
Dietary Supplement: vitamin D fortified yogurt drink
Dietary Supplement: vitamin D-calcium yogurt drink
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
Hide Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
Period Title: Overall Study
Started 30 30 30
Completed 30 30 30
Not Completed 0 0 0
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink Total
Hide Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
50.8  (6.6) 51.4  (5.4) 49.9  (6.2) 50.7  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
Female
18
  60.0%
16
  53.3%
9
  30.0%
43
  47.8%
Male
12
  40.0%
14
  46.7%
21
  70.0%
47
  52.2%
25-hydroxyvitamin D  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 30 participants 30 participants 30 participants 90 participants
50  (26) 47.5  (27) 51.3  (43) 48.8  (38.4)
Fasting serum glucose (FSG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 30 participants 30 participants 30 participants 90 participants
187  (57.1) 184.1  (63.8) 184  (57.3) 185  (58.8)
[1]
Measure Description: Fasting serum glucose concentration
Insulin   [1] 
Mean (Standard Deviation)
Unit of measure:  mU/L
Number Analyzed 30 participants 30 participants 30 participants 90 participants
7.7  (3.2) 7.7  (4.6) 7.6  (4.6) 7.6  (4.1)
[1]
Measure Description: Fasting serum Insulin concentration
HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 30 participants 30 participants 30 participants 90 participants
7.5  (1.5) 7.4  (1.8) 7.8  (1.9) 7.6  (1.7)
[1]
Measure Description: Hemoglobin A1c
TG   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 30 participants 30 participants 30 participants 90 participants
160.5  (100.7) 155.4  (65.9) 176.6  (91.0) 164.2  (86.6)
[1]
Measure Description: serum triglyceride concentration
Tchol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 30 participants 30 participants 30 participants 90 participants
187.5  (43.3) 177.5  (41.9) 187.7  (46.6) 182.4  (43.8)
[1]
Measure Description: serum total cholesterol concentration
LDL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 30 participants 30 participants 30 participants 90 participants
88.6  (25.9) 87.2  (25.1) 90.2  (27.9) 88.7  (26.0)
[1]
Measure Description: serum low density lipoprotein concentration
HDL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 30 participants 30 participants 30 participants 90 participants
50.8  (8.2) 46  (9.6) 47.2  (9.4) 48  (9.2)
[1]
Measure Description: serum High density lipoprotein concentration
1.Primary Outcome
Title Serum 25-hydroxyvitamin D
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: nmol/L
45.6  (45.4) 76.2  (28.4) 78.4  (40.8)
2.Secondary Outcome
Title Fasting Serum Glucose (FSG)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
203.3  (64.4) 171.2  (59.2) 174.3  (50)
3.Secondary Outcome
Title Insulin
Hide Description fasting serum insulin concentration
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mU/L
10.8  (5.5) 6.5  (3.3) 6.4  (3.1)
4.Secondary Outcome
Title Hemoglobin A1c (HbA1c)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: percent
8.7  (1.4) 7  (2.3) 7.8  (1.9)
5.Secondary Outcome
Title Serum Triglyceride (TG)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
181.3  (91.8) 155.2  (55.1) 161.1  (64.3)
6.Secondary Outcome
Title Serum Total Cholesterol (Tchol)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
197.3  (48.1) 182.8  (43.0) 178.5  (42.4)
7.Secondary Outcome
Title Serum Low Density Lipoprotein (LDL)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
93.5  (24.9) 91.1  (19.8) 96.3  (27.8)
8.Secondary Outcome
Title Serum High Density Lipoprotein (HDL)
Hide Description [Not Specified]
Time Frame 12-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
Hide Arm/Group Description:
2 bottle plain yogurt drink per day
2 bottle vitamin D-fortified yogurt drink per day
2 bottle vitamin D-calcium-fortified yogurt drink per day
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
51.8  (9.6) 46.1  (10) 48  (6.8)
Time Frame during the intervention (12-week)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
Hide Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
All-Cause Mortality
Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: T Neyestani
Organization: National nutrition and food technology institute
Phone: 0982122376471
Responsible Party: Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01229891     History of Changes
Other Study ID Numbers: 11024
First Submitted: October 27, 2010
First Posted: October 28, 2010
Results First Submitted: November 6, 2011
Results First Posted: January 16, 2012
Last Update Posted: January 16, 2012