Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tan Tock Seng Hospital
• Collaborators: Duke-NUS Graduate Medical School; National Healthcare Group, Singapore
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Patients who have undergone any form of bariatric surgery

• Patients known to have any malabsorption disorders

• Patients known to have osteoporosis or of baseline BMD scan shows osteoporosis as T score <-2.5SD (for randomisation)