Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) (VDIS)
Primary Purpose
Type 2 Diabetes Mellitus, Obesity, Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Vitamin D3(cholecalciferol)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, vitamin D, cholecalciferol, obesity
Eligibility 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
Sites / Locations
- Rashid Centre for Diabetes and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D3 group
Placebo group
Arm Description
supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months
Placebo (starch) capsules identical to vitamin D capsules in appearance
Outcomes
Primary Outcome Measures
glycemic control
HbA1c, Fasting Blood glucose, C-peptide
Secondary Outcome Measures
Lipid Profile
Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B
Vitamin D
Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase
Other metabolic markers
High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure
Obesity Parameter
Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass
Full Information
NCT ID
NCT02101151
First Posted
March 26, 2014
Last Updated
March 29, 2014
Sponsor
Rashid Centre for Diabetes and Research
1. Study Identification
Unique Protocol Identification Number
NCT02101151
Brief Title
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Acronym
VDIS
Official Title
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rashid Centre for Diabetes and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity, Hypovitaminosis D
Keywords
Type 2 diabetes mellitus, vitamin D, cholecalciferol, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 group
Arm Type
Experimental
Arm Description
supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (starch) capsules identical to vitamin D capsules in appearance
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3(cholecalciferol)
Other Intervention Name(s)
cholecalciferol
Primary Outcome Measure Information:
Title
glycemic control
Description
HbA1c, Fasting Blood glucose, C-peptide
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lipid Profile
Description
Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B
Time Frame
6 months
Title
Vitamin D
Description
Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase
Time Frame
6 months
Title
Other metabolic markers
Description
High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure
Time Frame
6 months
Title
Obesity Parameter
Description
Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass
Time Frame
6 monhts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rashid Centre for Diabetes and Research
City
Ajman
Country
United Arab Emirates
12. IPD Sharing Statement
Citations:
PubMed Identifier
25892603
Citation
Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D3 supplementation and body composition in persons with obesity and type 2 diabetes in the UAE: A randomized controlled double-blinded clinical trial. Clin Nutr. 2016 Feb;35(1):77-82. doi: 10.1016/j.clnu.2015.02.017. Epub 2015 Mar 24.
Results Reference
derived
PubMed Identifier
25406966
Citation
Sadiya A, Ahmed SM, Carlsson M, Tesfa Y, George M, Ali SH, Siddieg HH, Abusnana S. Vitamin D supplementation in obese type 2 diabetes subjects in Ajman, UAE: a randomized controlled double-blinded clinical trial. Eur J Clin Nutr. 2015 Jun;69(6):707-11. doi: 10.1038/ejcn.2014.251. Epub 2014 Nov 19.
Results Reference
derived
Learn more about this trial
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
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