The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency (VDD)
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.
Vitamin D Deficiency
Dietary Supplement: vitamin D3
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Change in Hba1c (%) in study groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]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%.
- Lipid profile [ Time Frame: 2 years ] [ Designated as safety issue: No ]Total cholesterol, LDL choleterol , HDL cholesterol, non HDL cholesterol, Triglycerides
- C-reactive protein [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Body Weight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum calcium [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum phosphore [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum PTH [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum creatinine [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- serum albumin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: vitamin D3 supplementatio
The study group participants will receive vitamin D3 supplementation (120,000 I.U per month)for 6 months
Dietary Supplement: vitamin D3
Other Name: Cholecalciferol
Placebo Comparator: placebo group
placebo group, 15 ml per month for 6 months
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).
ADMINISTRATIVE AND LEGAL OBLIGATIONS:
Individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties.
The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
Source and study documents will be locked under the supervision of the PI- principle investigator for 15 years.
Study documentations and storage The investigator should maintain a list of appropriately qualified people to whom trail duties are delegated.
All persons authorized to make entries and/or correction on CRF will be included on the investigators team list delegation log.
Study printout and electronic CRF's, ICF's and other study documents will be stored in the at Haemek medical center under the supervision of the PI. All identifying details will be completely erased.
The investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01991054
|Contact: avraham ishay, M.D||972 46494000 ext email@example.com|
|Contact: hila kfir, b.sc||972 46494000 ext firstname.lastname@example.org|
|Haemek medical center, endocrone clinic||Recruiting|
|Afula, Israel, 1834111|
|Contact: avraham ishay, M.D 972 46494000 ext 5556 email@example.com|
|Contact: hila kfir, b.sc 972 46494000 ext 5559 firstname.lastname@example.org|
|Principal Investigator: avraham ishay, M.D|
|Principal Investigator:||avraham ishay, M.D||haemek medical center|