A Double Blind Randomized Control Trial to Study the Effect of Long Term Vitamin D Supplementation on Peripheral Insulin Sensitivity in Apparently Healthy Middle Aged Centrally Obese Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- INsulin Sensitivity
研究概览
简要总结
Type 2 diabetes is a major public health problem in India with an estimated a prevalence of approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of Vitamin D supplementation on insulin/glucose metabolism have been conducted using small sample sizes in different subgroups document variable results (significant decrease in HbA1c concentration with insulin concentration in hemodialysis patients; insulin levels lower with oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in post menopausal women). A double blind randomized controlled trial conducted at our institute using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of insulin sensitivity. We therefore, plan to study the long term effect of vitamin D supplementation on peripheral insulin sensitivity.
详细描述
Volunteers will be recruited from amongst the preventive health check subjects, neighboring offices, hospital employees and corporate associates of SBISR after obtaining a detailed informed consent. The study will include 300 subjects with the following selection criteria.
INCLUSION CRITERIA
- 35 to 75 years of age
- Waist circumference (WC) ≥78 cm in men and ≥ 72 cm in women
Recruited subjects will be randomized into two groups on the basis of random numbers generated by a computer after pre-stratification by gender (to allow equal representation of both sexes) and baseline Vitamin D levels. The baseline information will be recorded on standardized questionnaire include age, education, marital status, annual household income, family history, smoking and alcohol use. A complete physical examination will be done including height, weight, waist circumference and blood pressure. Weight will be recorded on a manual weighing scale (sensitivity 500 g), height using SECA stadiometer (sensitivity 0.1 cm), waist circumference (WC) at the midpoint between the lower rib and iliac crest using a measuring tape (sensitivity 0.1 cm), and blood pressure using an OMRON electronic instrument (sensitivity 1 mmHg; accuracy 3 mmHg) validated in an earlier trial. Height, WC and weight will recorded with light clothing and without shoes. Three serial BP recordings from the right arm will be taken after 10 minutes of rest at 10 minute intervals in the sitting posture as per WHO recommendations. The mean of the three recordings will used for analysis. Daily sun exposure will be calculated by taking a detailed history of sun exposure separately during summers and winters and the type of clothing worn. Sun exposure will be calculated as hours of exposure per day x percentage of body surface area (BSA) exposed (calculated according to Wallace rule of nine). A detailed dietary assessment by the 24 hour recall method will be done at baseline to determine the dietary intake of calcium, phosphate and Vitamin D.
Consenting subjects will be advised to fast from 8 pm of the previous night. 10 ml of blood will be drawn at baseline for the following tests between 9 am to 10 am on the next day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35 to 75 years of age
- •Waist circumference (WC) ≥78 cm in men and ≥ 72 cm in women
排除标准
- •Diabetic- Fasting Blood Sugar >126 mg/dl or on anti-diabetic medication
- •Resting Blood Pressure>140/90 mmHg or on anti-hypertensive medication
- •Receiving/received Vitamin D or calcium supplementation in the previous 6 months
- •Chronic disease-renal/hepatic/malignancy/gastrointestinal
- •On any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, Vitamin D or Calcium metabolism
- •Febrile illness or infective morbidity in the past 10 days
研究组 & 干预措施
Vitamin D supplementation
Cholecalciferol sachets 120,000 IU monthly for 12 months
干预措施: Cholecalciferol (Drug)
placebo
placebo with same taste, color, odor
干预措施: placebo (Drug)
结局指标
主要结局
INsulin Sensitivity
时间窗: 1 year
次要结局
- symptoms of toxicity(1 year)
研究者
Dr Jitender Nagpal
PI
Sitaram Bhartia Institute of Science and Research