MedTrace Logo

Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria

NCT00283387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-12-16

Study results available
· View outcomes & findings →

Summary

The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients.

Hypothesis:

Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients.

Conditions

  • Hyperoxaluria

Interventions

DRUG

Betaine

Subjects were randomly assigned oral betaine 12 grams/day in subjects younger than 10 years of age, and 20 grams/day in subjects 10 years of age and older, in two divided doses, for 2 months.

DRUG

Placebo

Subjects received oral lactose placebo, in two doses daily, for 2 months.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Orphan Europe

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Carla G Monico, M.D. · Mayo Clinic Hyperoxaluria Center, Rochester MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00283387 on ClinicalTrials.gov