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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Obesity Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3 group

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

Group Type EXPERIMENTAL

Vitamin D3(cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Placebo group

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

Group Type PLACEBO_COMPARATOR

Vitamin D3(cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin D3(cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No