Effect of Vitamin D Supplementation on Hemoglobin A1c

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Genesys Regional Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01354262
First received: May 13, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

This is a prospective, randomized, non-blinded interventional study that will investigate the effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting vitamin D deficiency will alter the HbA1c level in patients with type 2 DM and lower than normal vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases HbA1c levels in patients with type 2 DM and vitamin D deficiency.


Condition Intervention Phase
Diabetes Mellitus
Vitamin D Deficiency
Dietary Supplement: Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Vitamin D Supplement Alter Serum Level of Glycosylated Hemoglobin in Adult Patients Between 34-74 Years With Type 2 Diabetes Mellitus and Vitamin D Deficiency?

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Change in serum levels of Hemoglobin A1c. [ Time Frame: Change from baseline assessed at 12 wk and 24 wk. ] [ Designated as safety issue: No ]
    Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at baseline and at 12 and 24 weeks from a fasting blood sample.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lower dose vitamin D
Fixed daily doses of 600 IU vitamin D oral supplementation.
Dietary Supplement: Vitamin D
600 IU daily oral supplementation
Experimental: Higher dose vitamin D
50,000 IU supplementation bi-monthly.
Dietary Supplement: Vitamin D
50,000 IU supplementation bi-monthly
No Intervention: Control Group
Patients will be followed from baseline to 12 and 24 week follow up. Patients do not receive any research treatment or intervention beyond the standard care of their diabetes. This group are patients with normal levels of Vitamin D.

Detailed Description:

The total number of study subjects expected to be enrolled in this study is about 150. Study subjects included in this study will be men and women between 34-69 years of age who have been diagnosed with type 2 DM based on at least one of the American Diabetic Association criteria. These criteria are 1) fasting blood glucose higher than 125 mg/dL once with symptoms of diabetes (increased urination, increased appetite, increased thirst) or two times without symptoms; 2) random blood glucose more than 200 mg/dL once with symptoms or two times without symptoms of diabetes; 3) two hour glucose tolerance test more than 200 mg/dL once with symptoms or two times without symptoms; or 4) a random glycosylated hemoglobin more than 6.5 % two times. The age group for this research was selected based on the review of the literature on diabetes and vitamin D. Patients with known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness, history of serum creatinine more than 2.0 mg/dL, vitamin D supplement more than 200 IU/day, inflammatory bowel disease and history of hypercalcemia and kidney stones will be excluded from this study. For this project, vitamin D deficiency is defined as serum vitamin D level lower than 30 ng/mL and uncontrolled diabetes is defined as HbA1C level above 7.0. Although there is more than one recommended normal level of vit. D in the blood, most experts agree that the optimum serum level of vitamin D should be above 30 ng/mL. All subjects will be receiving standard of care for DM offered to them by his or her physician.

The investigators will investigate if different but fixed doses of vitamin D (600 IU a day vs 50,000 IU once every other week) when given to patients with type 2 DM and vitamin D deficiency have different effects on HbA1c level at the end of 24 weeks. A baseline blood draw, and fasting blood draws will be taken at 12 and 24 weeks for blood sugar levels, Vit D levels, and HgbA1c. Subjects with vitamin D deficiency will be randomly assigned to either group 1 or 2 and will be supplemented with either 600 IU of vitamin D/day (Group 1) or 50,000 IU of vitamin D every 2 weeks for 24 weeks (Groups 2). Patients who are not vitamin D deficient will be followed as the control group (Group 3) and will not be given any vitamin D supplement.Research subjects will be advised not to take any vitamin D or multivitamin while participating in this study. Subjects will be given 100 tablets of 600 IU of vitamin D in a bottle if they belong to Group 1. If they have been advised to take vitamin D 50,000 IU once every 14 days (Group 2), they will be given altogether 13 tablets of 50,000 of vitamin D each in a separate brown envelope with date written on the envelop and subjects will be asked to take vitamin D only on the date written on the envelop.

  Eligibility

Ages Eligible for Study:   34 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Hgb A1c greater then 7.0
  • Adults aged 34 to 69 years.

Exclusion Criteria:

  • known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness,
  • history of serum creatinine more than 2.0 mg/dL,
  • vitamin D supplement more than 200 IU/day
  • history of inflammatory bowel disease, hypercalcemia or kidney stones
  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: NCT01354262

Contacts
Contact: Prabhat K Pokhrel, MD 810-715-4300 ppokhrel@genesys.org
Contact: Kimberly R Barber, PhD 810-606-7724 kbarber@genesys.org

Locations
United States, Michigan
Genesys East Flint Campus Clinic Recruiting
Flint, Michigan, United States, 48503
Contact: Prabhat Pokhrel, MD    810-715-4300    ppokhrel@genesys.org   
Contact: Kimberly R Barber, PhD    810-606-7724    kbarber@genesys.org   
Principal Investigator: Prabhat Pokhrel, MD         
Sub-Investigator: Kimberly R Barber, PhD         
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Prabhat K Pokhrel, MD Genesys Regional Medical Center
Study Director: Kimberly R Barber, PhD Genesys Regional Medical Center
  More Information

Publications:
Responsible Party: Prabhat Pokhrel, MD, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01354262     History of Changes
Other Study ID Numbers: GRMC 10 0023
Study First Received: May 13, 2011
Last Updated: May 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Genesys Regional Medical Center:
Diabetes
Vitamin D deficiency
Hemoglobin A1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 27, 2014