DIVINE: Dialysis Infection and Vitamin D In New England

NCT00892099 | Completed Results DMC

• 2 other identifiers: 2009P-000398R01DK084974
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

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 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

End Stage Renal Disease

Keywords

end stage renal disease; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Serum 25D Level

  12 weeks

Secondary Outcomes (5)

• Serum Calcium

  every 4 weeks for 12 weeks

• Serum Phosphate

  every 4 weeks for 12 weeks

• Serum 25-OH Vitamin D

  every 4 weeks for 12 weeks

• Serum 1,25(OH)2 Levels

  At week 12

• Parathyroid Hormone

  every 4 weeks for 12 weeks

Study Arms (3)

High Dose Ergocalciferol

EXPERIMENTAL

Receives 50,000 IU of ergocalciferol weekly

Drug: Ergocalciferol

Low Dose Ergocalciferol

EXPERIMENTAL

Receives 50,000 IU of ergocalciferol per month

Drug: Ergocalciferol

Placebo

PLACEBO COMPARATOR

Receives no ergocalciferol

Other: Placebo

Interventions

Ergocalciferol DRUG

50,000 IU tablet given weekly

Also known as: vitamin D

High Dose Ergocalciferol

Placebo OTHER

Placebo equivalent of ergocalciferol, given weekly as one tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Bhan I, Camargo CA Jr, Wenger J, Ricciardi C, Ye J, Borregaard N, Thadhani R. Circulating levels of 25-hydroxyvitamin D and human cathelicidin in healthy adults. J Allergy Clin Immunol. 2011 May;127(5):1302-4.e1. doi: 10.1016/j.jaci.2010.12.1097. Epub 2011 Feb 9. No abstract available.

  PMID: 21310475 BACKGROUND

• Ishir Bhan, Dorothy A Dobens, Caitlin A. Trottier, Julia Beth Wenger, Hector Tamez, Joseph James Deferio, Kathryn J. Lucchesi, Ravi I. Thadhani. The DIVINE Trial: Dialysis Infection and Vitamin D in New England J. Am. Soc. Nephrol 24:2013 (Abstract: SA-PO1082)

  RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Ishir Bhan
• Organization: Massachusetts General Hospital

ibhan@mgh.harvard.edu

617-726-3934

Study Officials

• Ravi Thadhani, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research in Nephrology

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 20, 2018
• Results First Posted: June 8, 2015

Record last verified: 2018-03

Locations

US (3)