N/A
N=105
DIVINE: Dialysis Infection and Vitamin D In New England
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00892099 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Serum 25D Level — 49.8; 38.3; 27.3 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ergocalciferol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum 25D Level |
49.8; 38.3; 27.3 | — |
| SECONDARY Serum Calcium |
8.8; 8.7; 8.8; 9.1; 8.9; 9.0 | — |
| SECONDARY Serum Phosphate |
4.2; 4.2; 4.1; 4.7; 4.7; 4.8 | — |
| SECONDARY Serum 25-OH Vitamin D |
21.8; 21.7; 22.3; 42.2; 33.6; 27.6 | — |
| SECONDARY Serum 1,25(OH)2 Levels |
95; 100; 120 | — |
| SECONDARY Parathyroid Hormone |
281; 214; 243; 253; 195; 243 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00892099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.