Vitamin D supplementation on surrogate markers of ageing, ageing-related genes, glycemic and metabolic markers in north Indian Individuals with the prediabetes

Not Applicable

• Registration Number: CTRI/2019/11/022106
• Lead Sponsor: Indian Councial of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Cross-sectional Study:

Inclusion Criteria: Individuals with prediabetes, aged 20-60 years.

Prospective Intervention Study:

Design: Randomized open labeled placebo-controlled trial.

Inclusion Criteria:

1.Pre-diabetes:

a.Fasting blood glucose >=100mg/dl and <125.99mg/dl, or

b.2-h plasma glucose >=140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and

2.Baseline blood level of 25 hydroxy vitamin D <30ng/dl.

3.Aged 20-60 years

Exclusion Criteria

Cross sectional

Exclusion Criteria:

1.Received Vitamin D or calcium supplementation in the previous six months.

2.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.

3.Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

4.Known case of diabetes mellitus, HIV infection and other endocrine disorders.

Prospective Study

1.Received Vitamin D and/or calcium supplementation in the previous six months.

2.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.)

3.Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.

4.Known case of HIV infection.

5.Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas.

6.Known case of diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and dietary profiles, blood pressure and phenotypic markers, sunlight exposure, anthropometric assessments [body mass index, circumferences and skinfolds, glycemic and lipid profile other metabolic parameters (serum Vitamin D, parathyroid hormone, calcium and phosphorus, fasting serum insulin and homeostasis model assessment, leukocyte telomerase length and telomerase activity and genetic polymorphismsTimepoint: Vitamin D supplementation could <br/ ><br>1.Increase/preserve leucocyte telomerase length and activity, thus having positive effects on ageing. <br/ ><br>2.Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
2.If vitamin D addition leads to longer life span as indicated by aging-associated surrogate markers, it may be cost-effective and novel way to slow ageing in Indian population. <br/ ><br> <br/ ><br>Measurements same as in visit 1 except genetic polymorphismTimepoint: 2 years