Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
1 other identifier
interventional
37
1 country
3
Brief Summary
The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Oct 2009
Shorter than P25 for not_applicable type-2-diabetes-mellitus
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMay 6, 2010
October 1, 2009
5 months
September 25, 2009
May 5, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c
3 months
Study Arms (2)
Vitamin D 2000 international units daily
EXPERIMENTALVitamin C 500mg daily
ACTIVE COMPARATORInterventions
Vitamin D3 2000 international unit tablets once daily for 3 months
Vitamin C 500mg tablets once daily for 3 months
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Hemoglobin A1c \>7% measured in the 3 months prior to randomization
- Age 21 to 75 years
You may not qualify if:
- Renal insufficiency (defined as CrCl \<30mL/min)
- Gestational diabetes
- Malabsorption syndrome
- Patients taking vitamin D supplements at doses \>400 international units daily
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Flower Hospital Family Medicine Residency
Sylvania, Ohio, 43560, United States
Center for Health Services
Toledo, Ohio, 43606, United States
Toledo Hospital Family Medicine Residency
Toledo, Ohio, 43606, United States
Related Publications (1)
Soric MM, Renner ET, Smith SR. Effect of daily vitamin D supplementation on HbA1c in patients with uncontrolled type 2 diabetes mellitus: a pilot study. J Diabetes. 2012 Mar;4(1):104-5. doi: 10.1111/j.1753-0407.2011.00164.x. No abstract available.
PMID: 22018074DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mate M Soric, PharmD
ProMedica Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 6, 2010
Record last verified: 2009-10