NCT01175798

Brief Summary

Dialysis patients often suffer from defects in their immune system (that part of the body which fights infection). Evidence suggests that Vitamin D deficiency may have a negative effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that by giving Vitamin D to dialysis patients who are deficient, we may help improve their immune system. This study will test that idea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2014

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

August 3, 2010

Results QC Date

September 15, 2014

Last Update Submit

September 15, 2014

Conditions

Vitamin D DeficiencyEnd-stage Renal Disease

Keywords

Vitamin D deficiencyEnd-stage renal diseaseImmunity

Outcome Measures

Primary Outcomes (1)

  • Change in 25OH-Vitamin D Level

    Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.

    1 year

Secondary Outcomes (1)

  • Change in Immune Parameters

    1 year

Study Arms (2)

No treatment (standard of care)

NO INTERVENTION

Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).

Vitamin D repletion

EXPERIMENTAL

Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).

Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

50,000 IU PO weekly x 6 weeks

Also known as: Vitamin D
Vitamin D repletion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Chronic hemodialysis treatments for at least 2 consecutive months

You may not qualify if:

  • History of acute renal failure requiring dialysis with potential for renal recovery
  • History of HIV/AIDS
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

  • Li L, Lin M, Krassilnikova M, Ostrow K, Bader A, Radbill B, Uribarri J, Tokita J, Leisman S, Lapsia V, Albrecht RA, Garcia-Sastre A, Branch AD, Heeger PS, Mehrotra A. Effect of cholecalciferol supplementation on inflammation and cellular alloimmunity in hemodialysis patients: data from a randomized controlled pilot trial. PLoS One. 2014 Oct 8;9(10):e109998. doi: 10.1371/journal.pone.0109998. eCollection 2014.

    PMID: 25296334DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyKidney Failure, Chronic

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Anita Mehrotra MD
Organization
Icahn School of Medicine at Mount Sinai
anita.mehrotra@mssm.edu
2122415153

Study Officials

  • Anita Mehrotra, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 22, 2014

Results First Posted

September 22, 2014

Record last verified: 2014-09

Locations

US(1)