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

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ClinicalTrials.gov Identifier: NCT01991054
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
avraham ishay, HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Vitamin D Deficiency Dietary Supplement: vitamin D3 Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: vitamin D3 supplementation
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
Dietary Supplement: vitamin D3
Other Name: Cholecalciferol



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Lipid profile [ Time Frame: 2 years ]
    Total cholesterol, LDL cholesterol , HDL cholesterol, non HDL cholesterol, Triglycerides

  2. C-reactive protein [ Time Frame: 2 years ]
  3. Body Weight [ Time Frame: 2 years ]
  4. Blood Pressure [ Time Frame: 2 years ]
  5. serum calcium [ Time Frame: 2 years ]
  6. serum phosphore [ Time Frame: 2 years ]
  7. serum PTH [ Time Frame: 2 years ]
  8. serum creatinine [ Time Frame: 2 years ]
  9. serum albumin [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991054


Locations
Israel
Haemek medical center, endocrone clinic
Afula, Israel, 1834111
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: avraham ishay, M.D haemek medical center

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
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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