The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency (VDD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
avraham ishay, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01991054
First received: November 7, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Vitamin D Deficiency
Dietary Supplement: vitamin D3
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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%.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991054

Contacts
Contact: avraham ishay, M.D 972 46494000 ext 5556 ishay_av@clalit.org.il
Contact: hila kfir, b.sc 972 46494000 ext 5559 hila_kf@clalit.org.il

Locations
Israel
Haemek medical center, endocrone clinic Not yet recruiting
Afula, Israel, 1834111
Contact: avraham ishay, M.D    972 46494000 ext 5556    ishay_av@clalit.org.il   
Contact: hila kfir, b.sc    972 46494000 ext 5559    hila_kf@clalit.org.il   
Principal Investigator: avraham ishay, M.D         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: avraham ishay, M.D Haemek medical center
  More Information

Additional Information:
Publications:

Responsible Party: avraham ishay, endocronologist, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01991054     History of Changes
Other Study ID Numbers: HGA1C vs D
Study First Received: November 7, 2013
Last Updated: November 25, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Diabetes mellitus
HgA1C
25(OH) vitamin D
HgA1C levels above 7.5%

Additional relevant MeSH terms:
Vitamin D Deficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014