Clinical trial NCT02101151: Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Official title: Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Hypovitaminosis D
Keywords: Type 2 diabetes mellitus
vitamin D
cholecalciferol
obesity
Lead sponsor: Rashid Centre for Diabetes and Research
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: glycemic control
timeFrame: 6 months
Secondary outcomes:
measure: Lipid Profile
timeFrame: 6 months
measure: Vitamin D
timeFrame: 6 months
measure: Other metabolic markers
timeFrame: 6 months
measure: Obesity Parameter
timeFrame: 6 monhts
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Rashid Centre for Diabetes and Research
Study officials:
References:
citation: Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D3 supplementation and body composition in persons with obesity and type 2 diabetes in the UAE: A randomized controlled double-blinded clinical trial. Clin Nutr. 2016 Feb;35(1):77-82. doi: 10.1016/j.clnu.2015.02.017. Epub 2015 Mar 24.
citation: Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D supplementation in obese type 2 diabetes subjects in Ajman, UAE: a randomized controlled double-blinded clinical trial. Eur J Clin Nutr. 2015 Jun;69(6):707-11. doi: 10.1038/ejcn.2014.251. Epub 2014 Nov 19.