Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
Launched by TIRANG R. NEYESTANI · Nov 8, 2010
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Type 2 diabetes
- • Informed consent
- • BMI between 25 to 35 kg/m2
- • Age: 30-45 years old
- • Willingness to maintain current body weight for the duration of the study
- • Willingness to maintain baseline lifestyle activities and routines for the duration of the study
- • Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study
- Exclusion Criteria:
- • History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders
- • Subjects receiving vitamin D or omega-3 supplement
- • Pregnancy , or lactation within the study period
- • Treatment with insulin
- • Treatment for weight reduction
- • Treatment for reducing serum lipids
About Tirang R. Neyestani
Tirang R. Neyestani is a dedicated clinical trial sponsor with a strong focus on advancing medical research and improving patient outcomes. With a commitment to ethical standards and regulatory compliance, Neyestani oversees a diverse portfolio of clinical studies aimed at evaluating innovative therapies and interventions. Their comprehensive approach encompasses strategic planning, robust study design, and meticulous data management, ensuring the integrity and reliability of trial results. By fostering collaboration among stakeholders, including research institutions and healthcare professionals, Tirang R. Neyestani plays a pivotal role in translating scientific discoveries into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tehran, , Iran, Islamic Republic Of
Tehran, , Iran, Islamic Republic Of
Tehran, , Iran, Islamic Republic Of
Patients applied
Trial Officials
Tirang R. Neyestani, Ph.D.
Study Chair
National Nutrition & Food technology Research institute, P.O. Box 19395-4741
Abolghasem Djazayeri, Professor
Study Chair
Tehran University of Medical Sciences
Sakineh Shab-Bidar, M.Sc.
Principal Investigator
Tehran University of Medical Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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