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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170468
First Posted: July 27, 2010
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
July 25, 2010
July 27, 2010
August 30, 2016
December 2011
December 2016   (Final data collection date for primary outcome measure)
The incidence of DM [ Time Frame: 2 years ]
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 ]
  • slope of 2-hour post challenge glucose level [ Time Frame: 2 years ]
  • area under the curve of BP [ Time Frame: 2 years ]
  • area under the curve of weight [ Time Frame: 2 years ]
  • area under the curve of 25 OH vitamin D level [ Time Frame: 2 years ]
  • fasting insulin to glucose ratio [ Time Frame: 2 years ]
  • incidence of hypercalcemia [ Time Frame: 2 years ]
  • incidence of hypercalciuria [ Time Frame: 2 years ]
  • time to develop DM [ Time Frame: 2 years ]
    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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
  • 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.
 
Active, not recruiting
500
December 2016
December 2016   (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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
 
NCT01170468
RAC 2101040
No
Not Provided
Not Provided
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
August 2016

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