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Vitamin D supplementation to reduce CardioVascular risk factors

Phase 4
Conditions
Health Condition 1: null- metabolic syndrome
Registration Number
CTRI/2012/08/002855
Lead Sponsor
St Johns Research Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
140
Inclusion Criteria

Assessment for inclusion in the study

Individuals will be included in the study if they satisfy all of the following conditions:

i)Age 35 to 65 years

ii)Waist circumference of 90cm or more in men, and 80cm or more in women

iii)Any two of the following four factors:

•raised TG level: > 150 mg/d, or specific treatment for this lipid abnormality

•reduced HDL cholesterol: < 40 mg/dL in males and < 50 mg/dL in females, or specific treatment for this lipid abnormality

•raised blood pressure: systolic BP 130 or diastolic BP 85 mm Hg, or treatment of previously diagnosed hypertension

• fasting plasma glucose (FPG) 100 mg/dL (5.6 mmol/L)

Exclusion Criteria

1.Known diabetes or pre-diabetes defined as a Fasting Blood Sugar >110 mg/dl.

2.Receiving/received Vitamin D or calcium supplementation in the previous 3 months

3. History of Chronic disease-renal/ hepatic/ malignancy /gastrointestinal ( Mal absorption syndromes )

4.Patients who have received Anticonvulsants, glucocorticoids or ART medication in the past one month

5.Pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction of insulin resistance calculated by HOMA IR at the end of 6 monthsTimepoint: Reduction of insulin resistance calculated by HOMA IR at month 6
Secondary Outcome Measures
NameTimeMethod
ATimepoint: NA
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