NCT01354262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

May 13, 2011

Last Update Submit

April 22, 2015

Conditions

Diabetes MellitusVitamin D Deficiency

Keywords

DiabetesVitamin D deficiencyHemoglobin A1c

Outcome Measures

Primary Outcomes (1)

  • Change in serum levels of Hemoglobin A1c.

    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.

    Change from baseline assessed at 12 wk and 24 wk.

Study Arms (3)

Lower dose vitamin D

EXPERIMENTAL

Fixed daily doses of 600 IU vitamin D oral supplementation.

Dietary Supplement: Vitamin D

Higher dose vitamin D

EXPERIMENTAL

50,000 IU supplementation bi-monthly.

Dietary Supplement: Vitamin D

Control Group

NO INTERVENTION

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.

Interventions

Vitamin DDIETARY_SUPPLEMENT

600 IU daily oral supplementation

Lower dose vitamin D

Eligibility Criteria

Age34 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys East Flint Campus Clinic

Flint, Michigan, 48503, United States

Location

Related Publications (2)

  • Avenell A, Cook JA, MacLennan GS, McPherson GC; RECORD trial group. Vitamin D supplementation and type 2 diabetes: a substudy of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438). Age Ageing. 2009 Sep;38(5):606-9. doi: 10.1093/ageing/afp109. Epub 2009 Jul 18. No abstract available.

    PMID: 19617604BACKGROUND

  • Aljabri KS, Bokhari SA, Khan MJ. Glycemic changes after vitamin D supplementation in patients with type 1 diabetes mellitus and vitamin D deficiency. Ann Saudi Med. 2010 Nov-Dec;30(6):454-8. doi: 10.4103/0256-4947.72265.

    PMID: 21060157BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Prabhat K Pokhrel, MD

    Ascension Health

    PRINCIPAL INVESTIGATOR

  • Kimberly R Barber, PhD

    Ascension Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

US(1)