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DIVINE: Dialysis Infection and Vitamin D In New England

NCT00892099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-04-20

Study results available
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Summary

Infection is the second-leading cause of death in individuals requiring dialysis treatment for kidney failure. New research suggests the high risk of infection may be due in part to low levels of vitamin D, which are extremely common in kidney disease. This study is designed to determine safe and effective ways to raise vitamin D levels while monitoring effects on the immune system.

Conditions

Interventions

DRUG

Ergocalciferol

50,000 IU tablet given weekly

DRUG

Ergocalciferol

50,000 IU tablet given monthly

OTHER

Placebo

Placebo equivalent of ergocalciferol, given weekly as one tablet

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ravi Thadhani, MD MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892099 on ClinicalTrials.gov