Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
1 other identifier
interventional
61
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 20, 2016
January 1, 2016
3.5 years
March 8, 2012
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Ferritin and CRP Levels
Collection at Baseline and at 6-weeks
Secondary Outcomes (1)
Restless Leg Questionnaire
Baseline
Study Arms (2)
Treatment
EXPERIMENTAL1. iron 3 mg/kg/day elemental iron FeSO4 up to 45 mg (dose to be determined by PI) 2. \+ vitamin C-250 mg chewable tab 3. \+ probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
Control
PLACEBO COMPARATOR1. iron 3 mg/kg/day elemental iron FeSO4 to 45 mg 2. \+ vitamin C-250 mg chewable tab 3. \+ placebo (identical capsule)
Interventions
probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
Eligibility Criteria
You may qualify if:
- Ages 5-18 years
- RLS defined by NIH criteria -definite or probable (see appendix)
- Serum ferritin level less than 50 mcg/l
- CRP less than 10 mg/l
You may not qualify if:
- Immune compromised
- Milk intolerant/allergic
- Known allergy or intolerance to probiotics for iron
- History of hematochromatosis
- IV catheter or indwelling medical device
- Chronic gastroenteritis or malabsorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
Related Publications (1)
Rosen GM, Morrissette S, Larson A, Stading P, Griffin KH, Barnes TL. Use of a Probiotic to Enhance Iron Absorption in a Randomized Trial of Pediatric Patients Presenting with Iron Deficiency. J Pediatr. 2019 Apr;207:192-197.e1. doi: 10.1016/j.jpeds.2018.12.026. Epub 2019 Feb 4.
PMID: 30732996DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Rosen, MD
Children's Hospitals and Clinics of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
June 12, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 20, 2016
Record last verified: 2016-01