NCT02101151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

March 26, 2014

Last Update Submit

March 29, 2014

Conditions

Type 2 Diabetes MellitusObesityHypovitaminosis D

Keywords

Type 2 diabetes mellitusvitamin Dcholecalciferolobesity

Outcome Measures

Primary Outcomes (1)

  • glycemic control

    HbA1c, Fasting Blood glucose, C-peptide

    6 months

Secondary Outcomes (4)

  • Lipid Profile

    6 months

  • Vitamin D

    6 months

  • Other metabolic markers

    6 months

  • Obesity Parameter

    6 monhts

Study Arms (2)

Vitamin D3 group

EXPERIMENTAL

supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months

Dietary Supplement: Vitamin D3(cholecalciferol)

Placebo group

PLACEBO COMPARATOR

Placebo (starch) capsules identical to vitamin D capsules in appearance

Dietary Supplement: Vitamin D3(cholecalciferol)

Interventions

Vitamin D3(cholecalciferol)DIETARY_SUPPLEMENT
Also known as: cholecalciferol
Placebo groupVitamin D3 group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

Location

Related Publications (2)

  • 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.

    PMID: 25892603DERIVED

  • 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.

    PMID: 25406966DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Nutritionist

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 2, 2014

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

AE(1)