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Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2

NCT01741181 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-11-18

No results posted yet for this study

Summary

Background and Objectives :

The presence of vitamin D deficiency in patients with type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular disease (CVD). We aim to see whether supplementation of vitamin D in these patients helps to improve the endothelial function (EF) a surrogate marker of CVD risk.

Hypothesis: Vitamin D supplementation in patients with T2DM and low serum 25(OH) D concentrations (\<30ng/ml) will improve EF as measured by the Endo-PAT machine by 0.4 units (30% improvement over baseline) and/or will result in a increase of EPCs (CD133+/KDR+) and CD45dim CD34+/KDR.

The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized to placebo or vitamin D3 for 16 weeks.

Methods:

This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit 60 T2DM patients with vitamin D deficiency or insufficiency. Out of these 60 patients , 30 patients will be started on vitamin D supplementation and 30 patients will be given a matched placebo. Endothelial function (EF) will be checked before and after supplementation to see a change in EF.

Significance of Project:

If this study shows a significant improvement of EF, it would justify larger scale studies to show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin D supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk.

Conditions

  • Diabetes Mellitus Type 2
  • Vitamin D Deficiency

Interventions

DRUG

Vitamin D supplementation

Vitamin D3 marketed by oneNine57

DRUG

Placebo Pill

Placebo pill supplied by oneNine 57 imported to Singapore with approval and import licence from HSA.

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • National Healthcare Group, Singapore

    collaborator OTHER_GOV

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Rinkoo Dalan, MBBS, FRCP · Tan Tock Seng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01741181 on ClinicalTrials.gov