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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 April 2013 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: April 8, 2013
Last verified: April 2013
History of Changes

July 25, 2010
April 8, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01170468 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
  • Drug: Vitamin D3
    Vitamin D3 5000 IU orally, daily for 2 years
    Other Name: cholecalciferol
  • Drug: Placebo
    Placebo orally, daily for 2 years
    Other Name: Placebo
  • Experimental: Vitamin D3
    Vitamin D3 5000 IU daily
    Intervention: Drug: Vitamin D3
  • Placebo Comparator: Placebo
    Placebo daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Muhammad M Hammami, MD, PhD 966 1 442 4527 muhammad@kfshrc.edu.sa
Saudi Arabia
 
NCT01170468
RAC 2101040
No
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
Not Provided
Principal Investigator: Muhammad M Hammami, MD, PhD King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP