Status:
COMPLETED
Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
Health and Social Care Research and Development , Northern Ireland
Royal Victoria Hospital, Belfast
Conditions:
Sub-optimal Vitamin D Status
Pre-diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 diab...
Eligibility Criteria
Inclusion
- Impaired glucose tolerance (Fasting glucose \<7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association
- Sub-optimal vitamin D status (\<50nmol/L)
Exclusion
- Diabetes mellitus
- Established cardiovascular disease
- Psychiatric problems
- Pregnant or lactating
- Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
- Excessive alcohol consumption (\>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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01889810
Start Date
August 1 2013
End Date
June 1 2016
Last Update
May 6 2023
Active Locations (1)
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1
Queen's University, Belfast
Belfast, Northern Ireland, United Kingdom, BT12 6BJ