The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency
Condition: Diabetes Mellitus; Vitamin D Deficiency
MeSH terms: Diabetes Mellitus; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

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).

      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.
    

Intervention name(s): vitamin D3
Intervention type(s): Dietary Supplement
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes mellitus; HgA1C; 25(OH) vitamin D; HgA1C levels above 7.5%