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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:
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 10, 2013
Last verified: December 2013
  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:


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 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 10, 2013
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014