NCT01153243

Brief Summary

Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4

Status
unknown

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

April 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

March 1, 2009

Enrollment Period

3.2 years

First QC Date

March 23, 2010

Last Update Submit

April 6, 2011

Conditions

Vitamin D DeficiencyDiabetes

Keywords

inflammatory markers

Outcome Measures

Primary Outcomes (1)

  • Levels of inflammatory markers

    baseline and 12 weeks

Secondary Outcomes (1)

  • Levels of Vitamin D, PTH and Calcium

    Baseline and 12 weeks

Study Arms (2)

Ergocalciferol

ACTIVE COMPARATOR

The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Drug: Ergocalciferol

Placebo pill

PLACEBO COMPARATOR

The investigators will give intervention group 12 weeks of placebo pill (in pill every week)

Drug: Placebo pill

Interventions

ErgocalciferolDRUG

Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Also known as: Drisdol, Vitamin D
Ergocalciferol
Placebo pillDRUG

The investigators will give control group 12 weeks of 1 placebo pill every week.

Placebo pill

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • African Americans
  • DM type 2

You may not qualify if:

  • symptomatic vitamin D deficiency
  • hypocalcemia
  • hypercalcemia
  • malabsorption
  • liver disease
  • patients with creatinine \> 1.5. (CKD \>/= 3)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D DeficiencyDiabetes Mellitus

Interventions

ErgocalciferolsVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Leon Fogelfeld, MD

    Cook County Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 23, 2010

First Posted

June 30, 2010

Study Start

April 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

April 7, 2011

Record last verified: 2009-03