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临床试验/CTRI/2015/01/005392
CTRI/2015/01/005392已完成不适用

A double-blind, randomized, placebo-controlled trial of the effect of vitamin D3 supplementation on long term glycemic control

Bangalore Baptist Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
percentage of change in HbA1c

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

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

结局指标

主要结局

percentage of change in HbA1c

时间窗: 3 months after first dose

次要结局

  • percentage of change in HbA1c in rural and urban settings(3 months after first dose)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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