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Does Vitamin D Improve Glycemic Control in Type II DM? (no)

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:
NCT01170442
First received: July 25, 2010
Last updated: December 11, 2011
Last verified: December 2011
History of Changes
  Purpose

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.


Condition Intervention Phase
Diabetes Mellitus
Vitamin D Deficiency
 Drug: vitamin D3 2000 IU
Drug: vitamin D3 5000 IU
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: Treatment
Official Title: Does Vitamin D Improve Glycemic Control in Type II DM? 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:
  • Area under the curve of HA1C. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve for BP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • area under the curve of weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • area under the curve for 25 OH vitamin D level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • area under the curve of fasting blood glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • area under the curve of 2 hour post breakfast glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • fasting insulin to glucose ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • incidence of hypercalcemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • incidence of hypercalciuria [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D3 2000 IU Drug: vitamin D3 2000 IU
vitamin D3 2000 IU orally, daily for 6 months
Other Name: cholecalciferol
Experimental: vitamin D3 5000 IU Drug: vitamin D3 5000 IU
vitamin D3 5000 IU orally, daily for 6 months
Other Name: cholecalciferol
Placebo Comparator: Placebo Drug: Placebo
placebo orally, daily for six months
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:

  • Type II diabetics living in Riyadh area 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 granulomatous conditions, liver disease, or kidney disease
  • Don't take anticonvulsants, barbiturates, or steroids.
  • Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
  • Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170442

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         muhammad@kfshrc.edu.sa    
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: NCT01170442     History of Changes
Other Study ID Numbers: RAC 2101039
Study First Received: July 25, 2010
Last Updated: December 11, 2011
Health Authority: Saudi Arabia: National Committee of Biological and Medical Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 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