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NCT Number: NCT02101151

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Avitaminosis Body Weight Deficiency Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypovitaminosis D Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3(cholecalciferol)

Dietary Supplement

Other names: cholecalciferol

Primary outcomes

  1. glycemic control

    Time frame: 6 months

    HbA1c, Fasting Blood glucose, C-peptide

Secondary outcomes

  1. Lipid Profile

    Time frame: 6 months

    Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B

  2. Vitamin D

    Time frame: 6 months

    Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase

  3. Other metabolic markers

    Time frame: 6 months

    High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure

  4. Obesity Parameter

    Time frame: 6 monhts

    Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass

Sponsors and collaborators

Lead sponsor

Rashid Centre for Diabetes and Research

Other

Registry information

Acronym: VDIS

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 2, 2014
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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