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Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome

NCT01617044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-01-20

No results posted yet for this study

Summary

A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron deficiency in children with Restless leg syndrome (RLS) and iron deficiency. One hundred children with diagnosis of RLS will be recruited over a two- year period.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics

probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Gerald Rosen, MD · Children's Hospitals and Clinics of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

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 NCT01617044 on ClinicalTrials.gov