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

Obesity Clinical Trial

— VDIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101151
• Other study ID #: VDIS
• 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

Related Conditions & MeSH terms

• Avitaminosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypovitaminosis D
• Obesity
• Rickets
• Type 2 Diabetes Mellitus
• Vitamin D Deficiency

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