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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01229891
First received: October 27, 2010
Last updated: December 10, 2011
Last verified: December 2011
History of Changes
Results First Received: November 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Plain Yogurt Drink     Vitamin D-fortified Yogurt Drink     Vitamin D-calcium Yogurt Drink  
STARTED     30     30     30  
COMPLETED     30     30     30  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Plain Yogurt Drink     Vitamin D-fortified Yogurt Drink     Vitamin D-calcium Yogurt Drink     Total  
Number of Participants  
[units: participants]
 		  30     30     30     90  
Age  
[units: years]
Mean ± Standard Deviation 		  50.8  ± 6.6     51.4  ± 5.4     49.9  ± 6.2     50.7  ± 6.1  
Gender  
[units: participants]
 		       
Female     18     16     9     43  
Male     12     14     21     47  
25-hydroxyvitamin D  
[units: nmol/L]
Mean ± Standard Deviation 		  50  ± 26     47.5  ± 27     51.3  ± 43     48.8  ± 38.4  
Fasting serum glucose (FSG) [1]
[units: mg/dL]
Mean ± Standard Deviation 		  187  ± 57.1     184.1  ± 63.8     184  ± 57.3     185  ± 58.8  
Insulin [2]
[units: mU/L]
Mean ± Standard Deviation 		  7.7  ± 3.2     7.7  ± 4.6     7.6  ± 4.6     7.6  ± 4.1  
HbA1c [3]
[units: percent]
Mean ± Standard Deviation 		  7.5  ± 1.5     7.4  ± 1.8     7.8  ± 1.9     7.6  ± 1.7  
TG [4]
[units: mg/dL]
Mean ± Standard Deviation 		  160.5  ± 100.7     155.4  ± 65.9     176.6  ± 91.0     164.2  ± 86.6  
Tchol [5]
[units: mg/dL]
Mean ± Standard Deviation 		  187.5  ± 43.3     177.5  ± 41.9     187.7  ± 46.6     182.4  ± 43.8  
LDL [6]
[units: mg/dL]
Mean ± Standard Deviation 		  88.6  ± 25.9     87.2  ± 25.1     90.2  ± 27.9     88.7  ± 26.0  
HDL [7]
[units: mg/dL]
Mean ± Standard Deviation 		  50.8  ± 8.2     46  ± 9.6     47.2  ± 9.4     48  ± 9.2  
[1] Fasting serum glucose concentration
[2] Fasting serum Insulin concentration
[3] Hemoglobin A1c
[4] serum triglyceride concentration
[5] serum total cholesterol concentration
[6] serum low density lipoprotein concentration
[7] serum High density lipoprotein concentration



  Outcome Measures
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1.  Primary:   Serum 25-hydroxyvitamin D   [ Time Frame: 12-week ]
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2.  Secondary:   Fasting Serum Glucose (FSG)   [ Time Frame: 12-week ]
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3.  Secondary:   Insulin   [ Time Frame: 12-week ]
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4.  Secondary:   Hemoglobin A1c (HbA1c)   [ Time Frame: 12-week ]
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5.  Secondary:   Serum Triglyceride (TG)   [ Time Frame: 12-week ]
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6.  Secondary:   Serum Total Cholesterol (Tchol)   [ Time Frame: 12-week ]
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7.  Secondary:   Serum Low Density Lipoprotein (LDL)   [ Time Frame: 12-week ]
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8.  Secondary:   Serum High Density Lipoprotein (HDL)   [ Time Frame: 12-week ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: T Neyestani
Organization: National nutrition and food technology institute
phone: 0982122376471
e-mail: neytr@yahoo.com


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Publications automatically indexed to this study:


Responsible Party: Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01229891     History of Changes
Other Study ID Numbers: 11024
Study First Received: October 27, 2010
Results First Received: November 6, 2011
Last Updated: December 10, 2011
Health Authority: Iran: Ministry of Health