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

This study is currently recruiting participants.
Verified December 2011 by King Faisal Specialist Hospital & Research Center
Sponsor:
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01170468
First received: July 25, 2010
Last updated: December 11, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Vitamin D3
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • The incidence of DM [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • slope of 2-hour post challenge glucose level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • area under the curve of BP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • area under the curve of weight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • area under the curve of 25 OH vitamin D level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • fasting insulin to glucose ratio [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • incidence of hypercalcemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • incidence of hypercalciuria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • time to develop DM [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.


Estimated Enrollment: 500
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3
Vitamin D3 5000 IU daily
 Drug: Vitamin D3
Vitamin D3 5000 IU orally, daily for 2 years
Other Name: cholecalciferol
Placebo Comparator: Placebo
Placebo daily
 Drug: Placebo
Placebo orally, daily for 2 years
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170468

Contacts
Contact: Muhammad M Hammami, MD, PhD 966 1 442 4527 muhammad@kfshrc.edu.sa

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Muhammad M Hammami, MD, PhD     966 1 4424527     muhammad@kfshrc.edu.sa    
Principal Investigator: Muhammad M Hammami, MD, PhD            
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Muhammad M Hammami, MD, PhD King Faisal Specialist Hospital & Research Center
  More Information

No publications provided

Responsible Party: Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01170468     History of Changes
Other Study ID Numbers: RAC 2101040
Study First Received: July 25, 2010
Last Updated: December 11, 2011
Health Authority: Saudi Arabia: National Committee of Biomedical and Medical Ethics

Keywords provided by King Faisal Specialist Hospital & Research Center:
Prediabetics
DM
vitamin D

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

ClinicalTrials.gov processed this record on October 17, 2012