A Trial to Study the Effect of Long Term Vitamin D Supplementation on Insulin Sensitivity

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Type 2 diabetes is a major public health problem in India with an estimated a prevalence of approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of Vitamin D supplementation on insulin/glucose metabolism have been conducted using small sample sizes in different subgroups document variable results (significant decrease in HbA1c concentration with insulin concentration in hemodialysis patients; insulin levels lower with oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in post menopausal women). A double blind randomized controlled trial conducted at our institute using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of insulin sensitivity. We therefore, plan to study the long term effect of vitamin D supplementation on peripheral insulin sensitivity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr Jitender Nagpal
• Collaborator: Indian Council of Medical Research
• Treatments: Cholecalciferol; Ergocalciferols; Insulin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. 35 to 75 years of age

2. Waist circumference (WC) ≥78 cm in men and ≥ 72 cm in women

Exclusion Criteria:

1. Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication

2. Resting Blood Pressure>140/90 mmHg or on anti-hypertensive medication

3. Receiving/received Vitamin D or calcium supplementation in the previous 6 months

4. Chronic disease-renal/hepatic/malignancy/gastrointestinal

5. On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism

6. Febrile illness or infective morbidity in the past 10 days