Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2

NCT01741181 | Completed Phase 4 DMC

• 1 other identifier: DIMENSION-03
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

25(OH)Vitamin D; Diabetes mellitus; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Endothelial function as assessed by the reactive hyperemia index and endothelial progenitor cells

  Endothelial function will be tested by using the EndoPAT machine which measures the reactive hyperemia index and by estimating the no. of endothelial progenitor cells in the peripheral blood by flow cytometry.

  16 weeks

Secondary Outcomes (2)

• Markers of endothelial cell activation and thrombogenesis

  16 weeks

• No. of circulating endothelial cells and endothelial microparticles

  16-20 weeks

Study Arms (2)

Vitamin D supplementation

ACTIVE COMPARATOR

Vitamin D3 tablets (cholecalciferol)

Drug: Vitamin D supplementation

Placebo pill

PLACEBO COMPARATOR

Placebo pill

Drug: Placebo Pill

Interventions

Vitamin D supplementation DRUG

Vitamin D3 marketed by oneNine57

Also known as: Vitamin D3-Cholecalciferol 1000units per tablet.

Vitamin D supplementation

Placebo Pill DRUG

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

Also known as: Placebo

Placebo pill

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with Type 2 Diabetes Mellitus
• HbA1c : 6.0-10.0%
• Male of female aged 21-80 years
• Stable Diabetes, blood pressure and hyperlipidemia medications (a 25% dose adjustment is allowed) in the last three months
• Baseline serum 25(0H)D concentration \<30ng/ml for randomisation

You may not qualify if:

• Baseline serum 25(OH)D concentration \>30ng/ml
• Baseline HbA1c\>10.1%
• Baseline hypercalcemia (Ca\>2.58 mmol/L)
• Known case of Primary Hyperparathyroidism
• Known to be on bisphosphonates
• Known to be on Vitamin D supplementation of 1000 units daily or more in the last one year.
• Chronic renal failure with eGFR\<30ml/min
• Known to have cirrhosis of the liver or transaminitis with ALT/AST \>3X ULN
• Patients with h/o sarcoidosis, renal calculi or any malignancy
• Patients on current treatment for tuberculosis
• Pregnancy and Lactation
• Women of childbearing potential not taking effective contraceptive measures.
• Patients on long term glucocorticoids or anti-retroviral drugs
• Patients on orlistat or other over the counter preparations that claim to block fat absorption.
• A change in the type of medications for hypertension, diabetes mellitus and hyperlipidemia in the last three months

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• National Healthcare Group, Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Vitamin D Deficiency; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Rinkoo Dalan, MBBS, FRCP

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

SG (1)