A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Change in Hba1c (%) in study groups
Study Overview
Brief Summary
Vitamin D plays a key role in keeping normal mineral balance and maintaining bone health. There is accumulating evidence linking deficient vitamin D status with both type 1 and type 2 diabetes.
The purpose of this study is to evaluate the effect of high dose vitamin D supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin D deficient patients with non-optimally controlled type 2 diabetes mellitus.
Detailed Description
This is a randomized, double blind, parallel group, clinical trial for 6 months duration.
The study group participants will receive vitamin D supplementation (120,000 IU per month) versus the placebo group for 6 months. glycemic control indexes will be measured in T2DM diagnosed study subjects.
Patient will be randomized 1:1 to one of two treatment groups. Vitamin D group vs placebo group.
Randomization kits will include either vitamin D or vitamin D placebo. Blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. Anthropometric measurements will be drawn as well, at the same time points.
Determination of sample size In order to find a 0.5 mean difference in HgA1C between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written inform consent must be obtained from the patient before any assessment is performed.
- •Male or female patient, 18 years or older.
- •Diabetes mellitus patients.
- •HgA1C levels on randomization above 7.5% in the last 6 months.
- •Low 25(OH) vitamin D levels : under 50nmol/l
Exclusion Criteria
- •Patient who are unable consume food orally.
- •Life expectancy under 7 month.
- •Unable to sign inform consent.
- •Patient unwilling or unable to comply with study procedure.
Arms & Interventions
placebo group
placebo group, 15 ml per month for 6 months
Intervention: vitamin D3 (Dietary Supplement)
vitamin D3 supplementation
The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months
Intervention: vitamin D3 (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Hba1c (%) in study groups
Time Frame: 2 years
We assume that the treatment with vitamin D will improve diabetes control, as assessed by Hba1c . The expected reduction in Hba1c levels will be 0.5%.
Secondary Outcomes
- serum albumin(2 years)
- Blood Pressure(2 years)
- Body Weight(2 years)
- serum calcium(2 years)
- serum phosphore(2 years)
- serum creatinine(2 years)
- C-reactive protein(2 years)
- serum PTH(2 years)
- Lipid profile(2 years)
Investigators
avraham ishay
endocronologist
HaEmek Medical Center, Israel