Trial | NCT02101151  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    87
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.
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.
Study Started
Jun 30
2012
Primary Completion
Dec 31
2012
Study Completion
Jun 30
2013
Last Update
Apr 02
2014
Estimate

Dietary Supplement Vitamin D3(cholecalciferol)

  • Other names: cholecalciferol

Vitamin D3 group Experimental

supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months

Placebo group Placebo Comparator

Placebo (starch) capsules identical to vitamin D capsules in appearance

Criteria 

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
No Results Posted