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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02101151
Other study ID # VDIS
Secondary ID
Status Completed
Phase N/A
First received March 26, 2014
Last updated March 29, 2014
Start date June 2012
Est. completion date June 2013

Study information

Verified date March 2014
Source Rashid Centre for Diabetes and Research
Contact n/a
Is FDA regulated No
Health authority United Arab Emirates: Ministry of Health, Reseach Ethics Committee, Al Qassimi Clinical Research Centre
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date June 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Vitamin D3(cholecalciferol)


Locations

Country Name City State
United Arab Emirates Rashid Centre for Diabetes and Research Ajman

Sponsors (1)

Lead Sponsor Collaborator
Rashid Centre for Diabetes and Research

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary glycemic control HbA1c, Fasting Blood glucose, C-peptide 6 months No
Secondary Lipid Profile Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B 6 months No
Secondary Vitamin D Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase 6 months No
Secondary Other metabolic markers High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure 6 months No
Secondary Obesity Parameter Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass 6 monhts No
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