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

February 26, 2018 updated by: avraham ishay, HaEmek Medical Center, Israel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Haemek medical center, endocrone clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Cholecalciferol
Placebo Comparator: placebo group
placebo group, 15 ml per month for 6 months
Dietary supplement: vitamin D3
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: 2 years
2 years
Blood Pressure
Time Frame: 2 years
2 years
Lipid profile
Time Frame: 2 years
Total cholesterol, LDL cholesterol , HDL cholesterol, non HDL cholesterol, Triglycerides
2 years
C-reactive protein
Time Frame: 2 years
2 years
Body Weight
Time Frame: 2 years
2 years
serum calcium
Time Frame: 2 years
2 years
serum phosphore
Time Frame: 2 years
2 years
serum PTH
Time Frame: 2 years
2 years
serum albumin
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: avraham ishay, M.D, Haemek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGA1C vs D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on vitamin D3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe