Status:
UNKNOWN
Vitamin D Supplementation on Surrogate Markers of Ageing, Ageing Genes, Glycemic and Metabolic Markers in North India
Lead Sponsor:
Diabetes Foundation, India
Conditions:
Vitamin D Supplementation
PreDiabetes
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
Prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of important for prevention o...
Detailed Description
Asian Indians develop metabolic syndrome and diabetes earlier than in most population. In other words, Asian Indians have all the risk factors which may predispose to accelerated ageing; insulin resis...
Eligibility Criteria
Inclusion
- Inclusion and Exclusion Criteria of Cross Sectional and Prospective Study:
- Cross-sectional Study:
- Individuals with prediabetes, aged 20-60 years.
Exclusion
- Received Vitamin D or calcium supplementation in the previous six months.
- On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
- Known case of diabetes mellitus, HIV infection and other endocrine disorders.
- Prospective Intervention Study:
- Design: Randomized open labeled placebo-controlled trial.
- Inclusion Criteria:
- Pre-diabetes:
- Fasting blood glucose ≥100mg/dl and \<125.99mg/dl, or
- 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 g anhydrous oral glucose), and
- Baseline blood level of 25 hydroxy vitamin D \<30ng/dl.
- Aged 20-60 years
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04025489
Start Date
March 1 2020
End Date
March 30 2024
Last Update
June 15 2023
Active Locations (1)
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1
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
Delhi, India