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

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ClinicalTrials.gov Identifier: NCT02101151
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.Amena Sadiya, Rashid Centre for Diabetes and Research

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Hypovitaminosis D Dietary Supplement: Vitamin D3(cholecalciferol) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013


Arm Intervention/treatment
Experimental: Vitamin D3 group
supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months
Dietary Supplement: Vitamin D3(cholecalciferol)
Other Name: cholecalciferol

Placebo Comparator: Placebo group
Placebo (starch) capsules identical to vitamin D capsules in appearance
Dietary Supplement: Vitamin D3(cholecalciferol)
Other Name: cholecalciferol




Primary Outcome Measures :
  1. glycemic control [ Time Frame: 6 months ]
    HbA1c, Fasting Blood glucose, C-peptide


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101151


Locations
United Arab Emirates
Rashid Centre for Diabetes and Research
Ajman, United Arab Emirates
Sponsors and Collaborators
Rashid Centre for Diabetes and Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Amena Sadiya, Senior Nutritionist, Rashid Centre for Diabetes and Research
ClinicalTrials.gov Identifier: NCT02101151     History of Changes
Other Study ID Numbers: VDIS
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Dr.Amena Sadiya, Rashid Centre for Diabetes and Research:
Type 2 diabetes mellitus
vitamin D
cholecalciferol
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Avitaminosis
Rickets
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents