A clinical trial to study the effect of supplementation with Vitamin D on the sugar control of diabetic patients

Completed

• Conditions: Diabetes mellitus type 2

• Registration Number: CTRI/2015/01/005392
• Lead Sponsor: Bangalore Baptist Hospital

Brief Summary

Arandomised double blind placebo controlled trial to study the

effect ofsupplementation of 60,000 units of cholecalciferol per month

onglycemic control in 96 diabetic patients at a single centre in

SouthIndia. The primary outcome variable is a change in

percentage of HbA1c at the end of 3 months. Thisstudy attempts to study the role (if any) that Vitamin D has on glycemiccontrol in diabetics .  If (as pastresearch suggests) Vitamin D plays a role in modifying the control of sugars inthe diabetic population it could prove to be a safe, cost effective and widelyapplicable add- on to the current standard of care in Diabetes management

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-14
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 1)Adults 2)Above the age of 35 yrs 3)Diagnosis of diabetes mellitus ie.
• fasting blood values more than 125mg/dl, random blood sugar values of 140 mg/dl or more OR on current anti- hyperglycemic treatment 4) HbA1c values in between 6.5% to 8 % 5) who are willing to participate in the study 6) Willing to undergo a repeat glycosylated Hb testing after a period of 3 months.

Exclusion Criteria

• People on Vitamin D supplementation previously for other indications.
• Anaemic people or those on iron supplementation Chronic renal or liver disease Hyperparathyroidism Renal calculi.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of change in HbA1c	3 months after first dose

Secondary Outcome Measures

Name	Time	Method
percentage of change in HbA1c in rural and urban settings	3 months after first dose

Trial Locations

Locations (1)

Bangalore Baptist hospital; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Baptist hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Shaheen

Principal investigator

8971988347

shaheenchowdhury@rediffmail.com