Vitamin D Supplementation on Surrogate Markers of Ageing, Ageing Genes, Glycemic and Metabolic Markers in North India
Vitamin D Supplementation, PreDiabetes, Aging
About this trial
This is an interventional prevention trial for Vitamin D Supplementation focused on measuring Pre-diabetes, Type 2 Diabetes, Genes, Supplementation
Eligibility Criteria
Inclusion and Exclusion Criteria of Cross Sectional and Prospective Study:
Cross-sectional Study:
Inclusion Criteria: Individuals with prediabetes, aged 20-60 years.
Exclusion Criteria:
- 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
Exclusion Criteria:
- Received Vitamin D and/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 (e.g. metformin, thiazolidinediones, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steroids, calcitonin etc.)
- Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
- Known case of HIV infection.
- Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas.
- Known case of diabetes mellitus.
Sites / Locations
- Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and EndocrinologyRecruiting
Arms of the Study
Arm 1
Experimental
Vitamin D and Placebo
Doses of cholecalciferol (commercial name, Calcirol) 60,000IU (sachets, dissolved in half glass milk) once per week for eight weeks to intervention group and placebo (Lactose Granules) to the placebo group according to the random numbers generated by the computer.