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Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Prediabetics, DM, vitamin D

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
  • Who consume no more than one serving of milk/day
  • Do not take vitamin supplement
  • Habitually have less than 10 hour of sun exposure per week
  • Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
  • Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Sites / Locations

  • King Faisal Specialist Hospital & Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

Vitamin D3 5000 IU daily

Placebo daily

Outcomes

Primary Outcome Measures

The incidence of DM
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

Secondary Outcome Measures

slope of fasting glucose level
slope of 2-hour post challenge glucose level
area under the curve of BP
area under the curve of weight
area under the curve of 25 OH vitamin D level
fasting insulin to glucose ratio
incidence of hypercalcemia
incidence of hypercalciuria
time to develop DM
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

Full Information

First Posted
July 25, 2010
Last Updated
March 6, 2018
Sponsor
King Faisal Specialist Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01170468
Brief Title
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
Official Title
Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollement
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 15, 2014 (Actual)
Study Completion Date
January 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established. The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Prediabetics, DM, vitamin D

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
Vitamin D3 5000 IU daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Vitamin D3 5000 IU orally, daily for 2 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally, daily for 2 years
Primary Outcome Measure Information:
Title
The incidence of DM
Description
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
slope of fasting glucose level
Time Frame
2 years
Title
slope of 2-hour post challenge glucose level
Time Frame
2 years
Title
area under the curve of BP
Time Frame
2 years
Title
area under the curve of weight
Time Frame
2 years
Title
area under the curve of 25 OH vitamin D level
Time Frame
2 years
Title
fasting insulin to glucose ratio
Time Frame
2 years
Title
incidence of hypercalcemia
Time Frame
2 years
Title
incidence of hypercalciuria
Time Frame
2 years
Title
time to develop DM
Description
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l Who consume no more than one serving of milk/day Do not take vitamin supplement Habitually have less than 10 hour of sun exposure per week Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad M Hammami, MD, PhD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

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Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

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