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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.Amena Sadiya, Rashid Centre for Diabetes and Research
ClinicalTrials.gov Identifier:
NCT02101151
First received: March 26, 2014
Last updated: March 29, 2014
Last verified: March 2014
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Obesity
Hypovitaminosis D
Dietary Supplement: Vitamin D3(cholecalciferol)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Rashid Centre for Diabetes and Research:

Primary Outcome Measures:
  • glycemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HbA1c, Fasting Blood glucose, C-peptide


Secondary Outcome Measures:
  • Lipid Profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B

  • Vitamin D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase

  • Other metabolic markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure

  • Obesity Parameter [ Time Frame: 6 monhts ] [ Designated as safety issue: No ]
    Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass


Enrollment: 87
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
n/a
Other Name: cholecalciferol
Placebo Comparator: Placebo group
Placebo (starch) capsules identical to vitamin D capsules in appearance
Dietary Supplement: Vitamin D3(cholecalciferol)
n/a
Other Name: cholecalciferol

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02101151

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

No publications provided

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
Study First Received: March 26, 2014
Last Updated: March 29, 2014
Health Authority: United Arab Emirates: Ministry of Health, Reseach Ethics Committee, Al Qassimi Clinical Research Centre

Keywords provided by Rashid Centre for Diabetes and Research:
Type 2 diabetes mellitus
vitamin D
cholecalciferol
obesity

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

ClinicalTrials.gov processed this record on September 14, 2014