Vitamin D Replacement in Insulin Resistant South Asians
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
University of Leicester
Treatments:
Cholecalciferol Ergocalciferols Insulin Vitamin D Vitamins