Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) (VDIS)

Rashid Centre for Diabetes and Research

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Obesity

Hypovitaminosis D

Treatments

Dietary Supplement: Vitamin D3(cholecalciferol)

Study type

Interventional

Funder types

Other

Identifiers

NCT02101151

VDIS

Details and patient eligibility

About

The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism, evidence from randomized and adequately powered placebo-controlled intervention trials is needed.The trials available on the effect of Vitamin D supplementation are not conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D supplementation on glycemic control and obesity parameters.

Full description

Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and type 2 diabetes mellitus. In contrast to the findings of the observational studies, the supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive conclusions, but it does suggest that supplementation at an early stage in the development of diabetes may be of benefit in delaying progression to clinical T2DM by increasing the pancreatic insulin release and improved insulin resistance plus impaired glucose tolerance.There is also speculation on role of vitamin D in physiology of weight loss and body composition.However, there have been multiple inconsistencies within the reported trial i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.

Hence the randomised clinical trial was undertaken to study the effect of vitamin D (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin D deficient obese type 2 diabetic subjects.

Enrollment

87 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

United Arab Emirates national
Male or Female
Age 30-65 years
Diagnosed as type 2 diabetes
Body Mass Index ≥30 kg/m2
Serum 25 hydroxy Vitamin D ≤ 50nmol/L

Exclusion criteria

Type 1 diabetes mellitus
History or evidence of liver failure (elevated liver function tests) or renal failure ( elevated creatinine)
History of malabsorption syndrome.
On vitamin D Supplementation
On hormone replacement therapy
On corticosteroids, anticonvulsants, AIDS medication