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Trace Element Replenishment Study in Hemodialysis Patients

NCT01473914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-12-16

No results posted yet for this study

Summary

A pilot randomized trial that compares a new renal nutritional supplement with the standard renal vitamin.

The primary objective is to compare two doses (medium and high) of the new supplement with the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD).

Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger trial.

Conditions

Interventions

DIETARY_SUPPLEMENT

Low dose: supplemental zinc, selenium and vitamin E

1. ZINC 25mg (AS ZINC SULFATE) 2. SELENIUM 50 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU

DIETARY_SUPPLEMENT

Standard renal vitamin: B and C renal vitamin

1. BIOTIN 300 MCG 2. D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG 3. FOLIC ACID 1 MG 4. NIACINAMIDE 20 MG 5. VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG 6. VITAMIN B12(CYANOCOBALAMIN) 6 MCG 7. VITAMIN B2 (RIBOFLAVIN) 1.7 MG 8. VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG 9. VITAMIN C (ASCORBIC ACID) 100 MG 10. INERT FILLER (CORNSTARCH)

DIETARY_SUPPLEMENT

Medium dose: supplemental zinc, selenium and vitamin E

1. ZINC 50 mg (AS ZINC SULFATE) 2. SELENIUM 75 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • Marcello Tonelli

    lead OTHER

Principal Investigators

  • Marcello A Tonelli, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Canada

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 NCT01473914 on ClinicalTrials.gov