Vitamin D Supplementation on Surrogate Markers of Ageing, Ageing Genes, Glycemic and Metabolic Markers in North India

NCT04025489 | Unknown DMC

• 1 other identifier: DFI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 of diabetes. It is not clear if apparent accelerated aging in Indian population associated with heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dys-metabolic state etc. could, besides lifestyle factors, be related to vitamin D deficiency, or ageing-related genes, or interaction between the two. This study is based on the assumption that the supplementation of vitamin d could lead to reversal to normal glucose regulation and may slow aging process in individuals with pre-diabetes.

Conditions

Vitamin D Supplementation; PreDiabetes; Aging

Keywords

Pre-diabetes; Type 2 Diabetes; Genes; Supplementation

Outcome Measures

Primary Outcomes (1)

• Investigation of gene polymorphism and other markers in 500 subjects

  single nucleotide polymorphisms \[ACTN3, VDR, FOXO3A, SIRT1 and MSTN\] Asian Indians with prediabetes.

  1 year

Secondary Outcomes (1)

• Effect of vitamin d supplementation on raging and other metabolic measures.

  2 year

Study Arms (1)

Vitamin D and Placebo

EXPERIMENTAL

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.

Dietary Supplement: Randomized control trial of vitamin D supplementation

Interventions

Randomized control trial of vitamin D supplementation DIETARY_SUPPLEMENT

This open-label randomized placebo-controlled prospective trial will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one-year intervention. As mentioned above, genes related to ageing will be evaluated. Effects on polymorphisms of pro-ageing genes will be assessed.

Vitamin D and Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Cross-sectional Study:
• 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.
• Pre-diabetes:
• Fasting blood glucose ≥100mg/dl and \<125.99mg/dl, or
• 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
• 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.

Sponsors & Collaborators

• Diabetes Foundation, India: lead

Study Sites (1)

Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology

Delhi, India

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Central Study Contacts

Anoop Misra, MD

CONTACT

01141759672; anoopmisra@gmail.com

Surya P Bhatt, PhD

CONTACT

919810085720; suryabhat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Presidant

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: July 19, 2019
• Study Start: March 1, 2020
• Primary Completion: February 28, 2024
• Study Completion: March 30, 2024
• Last Updated: June 15, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)