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N/A N=66 Randomized Quadruple-blind Prevention

Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study

Sub-optimal Vitamin D Status · Pre-diabetes · Insulin Resistance

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Insulin Resistance — 37.4; 36.3 μmol/kg/min (Step 2 GIR corrected)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Vitamin D3 supplementation (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Queen's University, Belfast
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Insulin Resistance
37.4; 36.3
SECONDARY
Change in Vitamin D Status
SECONDARY
Change in Markers of Cardiovascular Risk
SECONDARY
Change in Carotid-femoral Pulse Wave Velocity (PWV)
SECONDARY
Change in Hand Grip Strength
SECONDARY
Health Status

Summary

Insulin resistance is a state where the body does not respond as it should to the insulin it produces. Individuals who are insulin resistant are at increased risk of both heart disease and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease, independent of other recognised risk factors. Interventions that prevent or reverse insulin resistance may help to attenuate risk of heart disease and diabetes. A number of randomised controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin D on insulin resistance and other cardiovascular risk markers but experts have stated that further studies are required. Importantly, these studies should use appropriate endpoints, provide a high enough dose of vitamin D to optimise vitamin D status, and they should be conducted in clearly defined populations, The vitamin D trial we propose addresses these issues and aims to evaluate a potentially straightforward and low cost health care intervention for populations at highrisk of heart disease and diabetes. Specifically, this study would provide clinically relevant information on the metabolic effects of optimising vitamin D status in these high risk patients. This has clear economic and social implications given the current, and projected, burden of heart disease and diabetes. This study will investigate the effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease using the gold standard euglycaemic hyperinsulinaemic clamp method.

Eligibility Criteria

Inclusion Criteria

  • Impaired glucose tolerance (Fasting glucose 28 Units/week men or >21 Units/week women)
  • Already taking vitamin D supplements > 10 µg/d
  • Medical conditions or medications that could influence vitamin D metabolism
  • History of kidney stones
  • Hypercalcaemia
  • Hyperparathyroidism
  • Significant liver and renal disease (liver function tests >3x upper limit of normal and glomerular filtration rate <30ml/min)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01889810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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