Status:
COMPLETED
DIVINE: Dialysis Infection and Vitamin D In New England
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 vita...
Detailed Description
We hypothesize that a profound deficiency of nutritional vitamin D (25-hydroxyvitamin D, 25D) in end-stage renal disease (ESRD) leads to an altered immune response, predisposing to early morbidity and...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 18 years
- Initiating chronic hemodialysis 3x/wk at Massachusetts General Hospital, Brigham and Women's Hospital or Beth Israel Deaconess Medical Center with planned transfer to Massachusetts chronic facility
- Serum 25D \< 32 ng/ml
- Corrected serum calcium \< 10.2 mg/dl
- Serum phosphate \< 5.5 mg/dl
- Serum albumin \> 3 g/dL
- Informed consent
- Exclusion Criteria
- Pregnant or breastfeeding
- Women of childbearing potential not practicing one of the following measures of birth control: double-barrier method, hormonal contraceptives for at least 3 months prior to and during study, monogamous relationship with vasectomized partner, total abstinence from sexual intercourse with men during study.
- HIV positive
- History of allergic reaction to ergocalciferol
- Investigator considers subject unsuitable for any reason
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00892099
Start Date
November 1 2009
End Date
October 1 2014
Last Update
April 20 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115