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Vitamin D Replacement in Insulin Resistant South Asians

NCT01385345 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-01-30

No results posted yet for this study

Summary

This study will test the hypothesis that 6 months of periodic high dose Vitamin D3 replacement (200,000 and 100,000 units cholecalciferol, oral liquid drops at 6 to 8 week intervals) followed in-between by daily 1000 units, decreases insulin resistance by HOMA2-IR ≥ 0.36, in comparison to control, standard dose Vitamin D3 1000IU/ day for 6 months, in south Asians with both Vitamin D deficiency (defined as 25 Hydroxy vitamin D \< 25nmol/l) and insulin resistance (defined as HOMA1 -IR≥ 1.93).

The hypothesis formed suggests that insulin resistance developed in South Asians is explained, at least in part, by the presence of Vitamin D Deficiency (VDD). Therefore if the VDD is reversed/ 'normalised into target range' using Vitamin D therapy in individuals at risk of diabetes, then markers of insulin resistance should reduce from baseline values. However, current UK recommended doses of Vitamin D do not adequately replenish severe VDD, common in South Asians, back into the target range and therefore will not reduce insulin resistance markers. Therefore only higher pharmacological doses are able to replace severe Vitamin D deficiency adequately and improve insulin resistance markers.

Conditions

Interventions

DRUG

Vitamin D3 cholecalciferol

High dose Vitamin D3 (200,000 units followed by 100,000 units x 3 over 6 months) plus daily 1,000 units Vitamin D3 per day vs only daily 1,000 units Vitamin D3 per day

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Principal Investigators

  • Melanie J Davies, MD · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385345 on ClinicalTrials.gov