ACTRN12609000043235RecruitingPhase 4
Impact of vitamin D and calcium supplementation on the metabolic profile of glucose intolerant and vitamin D deficient obese subjects: a double blind, randomised and controlled trial
Professor Peter Ebeling0 sites160 target enrollmentStarted: January 20, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Vitamin D deficiency; overweight or obese as defined by a body-mass index (BMI) between 25-35 kg/m2; impaired fasting glucose or impaired glucose tolerance confirmed with a 75g 2h oral glucose tolerance test (OGTT).
Exclusion Criteria
- •Pregnancy; Breast-feeding; Renal insufficiency; Cirrhosis; Malabsorption; Hypercalcemia; Hypercalciuria; History of nephrolithiasis; Previous non-traumatic fractures; Active or chronic inflammatory disease;Medications known to affect vitamin D, calcium or bone metabolism over the last 3 months; Pharmacological treatment for obesity or medications known to alter glucose metabolism over the last 3 months; Bariatric surgery planned in the next six months or patients who had undergone bariatric surgery in the past; Commenced regular physical activity (more than 3 times/week) in the last 3 months; More than a 5% change in weight in the last 3 months.
Investigators
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