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

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ClinicalTrials.gov Identifier: NCT01170468
Recruitment Status : Active, not recruiting
First Posted : July 27, 2010
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vitamin D3 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. slope of fasting glucose level [ Time Frame: 2 years ]
  2. slope of 2-hour post challenge glucose level [ Time Frame: 2 years ]
  3. area under the curve of BP [ Time Frame: 2 years ]
  4. area under the curve of weight [ Time Frame: 2 years ]
  5. area under the curve of 25 OH vitamin D level [ Time Frame: 2 years ]
  6. fasting insulin to glucose ratio [ Time Frame: 2 years ]
  7. incidence of hypercalcemia [ Time Frame: 2 years ]
  8. incidence of hypercalciuria [ Time Frame: 2 years ]
  9. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170468


Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia, 11211
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

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
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Muhammad Maher Hammami, 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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents