Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Oct 2009
Shorter than P25 for phase_2 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 28, 2010
CompletedResults Posted
Study results publicly available
January 16, 2012
CompletedJanuary 16, 2012
December 1, 2011
5 months
October 27, 2010
November 6, 2011
December 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum 25-hydroxyvitamin D
12-week
Secondary Outcomes (7)
Fasting Serum Glucose (FSG)
12-week
Insulin
12-week
Hemoglobin A1c (HbA1c)
12-week
Serum Triglyceride (TG)
12-week
Serum Total Cholesterol (Tchol)
12-week
- +2 more secondary outcomes
Study Arms (3)
Plain yogurt drink
PLACEBO COMPARATORdaily intake of two bottle (250 mL) plain yogurt drink
vitamin D-fortified yogurt drink
EXPERIMENTALdaily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
vitamin D-calcium yogurt drink
EXPERIMENTALdaily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
Interventions
daily intake of two bottle of plain yogurt drink
daily intake of two bottle of 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 package
Eligibility Criteria
You may qualify if:
- to 50 years,
- Fasting blood glucose ≥ 126 mg/dl
You may not qualify if:
- Receiving vitamin D or calcium or omega-3 supplements within the last three months,
- On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
- Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
- Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Nikooyeh B, Shariatzadeh N, Rismanchi M, Hollis BW, Neyestani TR. Daily intake of yogurt drink fortified either with vitamin D alone or in combination with added calcium causes a thyroid-independent increase of resting metabolic rate in adults with type 2 diabetes: a randomized, double-blind, clinical trial. Appl Physiol Nutr Metab. 2021 Nov;46(11):1363-1369. doi: 10.1139/apnm-2021-0248. Epub 2021 Jun 2.
PMID: 34077684DERIVEDHeravifard S, Neyestani TR, Nikooyeh B, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Zahedirad M, Tayebinejad N, Salekzamani S, Khalaji N, Gharavi A. Regular consumption of both vitamin D- and calcium- and vitamin D-fortified yogurt drink is equally accompanied by lowered blood lipoprotein (a) and elevated apoprotein A1 in subjects with type 2 diabetes: a randomized clinical trial. J Am Coll Nutr. 2013;32(1):26-30. doi: 10.1080/07315724.2013.767659.
PMID: 23875809DERIVEDNeyestani TR, Nikooyeh B, Alavi-Majd H, Shariatzadeh N, Kalayi A, Tayebinejad N, Heravifard S, Salekzamani S, Zahedirad M. Improvement of vitamin D status via daily intake of fortified yogurt drink either with or without extra calcium ameliorates systemic inflammatory biomarkers, including adipokines, in the subjects with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jun;97(6):2005-11. doi: 10.1210/jc.2011-3465. Epub 2012 Mar 22.
PMID: 22442277DERIVEDNikooyeh B, Neyestani TR, Farvid M, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Gharavi A, Heravifard S, Tayebinejad N, Salekzamani S, Zahedirad M. Daily consumption of vitamin D- or vitamin D + calcium-fortified yogurt drink improved glycemic control in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2011 Apr;93(4):764-71. doi: 10.3945/ajcn.110.007336. Epub 2011 Feb 2.
PMID: 21289226DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- T Neyestani
- Organization
- National nutrition and food technology institute
Study Officials
- STUDY CHAIR
Tirang R. Neyestani, PhD
National Nutrition and Food Technology Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
October 27, 2010
First Posted
October 28, 2010
Study Start
October 1, 2009
Primary Completion
March 1, 2010
Study Completion
September 1, 2010
Last Updated
January 16, 2012
Results First Posted
January 16, 2012
Record last verified: 2011-12