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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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:
NCT01170442
First received: July 25, 2010
Last updated: December 10, 2013
Last verified: December 2013
  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:


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 2013 (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
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: 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 10, 2013
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 July 28, 2014