Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
Primary Purpose
Iron Deficiency, Restless Leg Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency focused on measuring Iron, Deficiency, Restless, Leg
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Children's Hospitals and Clinics of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
iron 3 mg/kg/day elemental iron FeSO4 up to 45 mg (dose to be determined by PI) + vitamin C-250 mg chewable tab + probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
iron 3 mg/kg/day elemental iron FeSO4 to 45 mg + vitamin C-250 mg chewable tab + placebo (identical capsule)
Outcomes
Primary Outcome Measures
Change in Ferritin and CRP Levels
Secondary Outcome Measures
Restless Leg Questionnaire
Full Information
NCT ID
NCT01617044
First Posted
March 8, 2012
Last Updated
January 19, 2016
Sponsor
Children's Hospitals and Clinics of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01617044
Brief Title
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
Official Title
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome-A Double-blind, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Project Summary:
Iron deficiency is the most common micronutrient deficiency in the world and is associated with significant adverse health effects including: cognitive deficits, immune deficiency, anemia, fatigue, and increased mortality. RLS affects 5 to 10% of adults in the United States and 2% of children. The prevalence of RLS in children with attention deficit hyperactivity disorder (ADHD) is estimated to be 12 to 35%. Iron deficiency has been recognized as an important factor in RLS, and the current recommendation for adults and children with RLS is to maintain serum ferritin level above 50 mcg/l. A common problem in the treatment of iron deficiency is that oral iron is poorly absorbed.
Probiotics are a group of microorganisms that benefit the host and are available naturally in fermented foods or as oral supplements. Naturally occurring probiotics, such as yogurt have been used to promote human health for millennia. Probiotic oral supplements have been proven effective and are currently approved for use in pediatrics in the treatment of: acute diarrhea, antibiotic associated diarrhea, and atopy associated with cow milk allergy; and there is some evidence that probiotics may be useful in the treatment of irritable bowel syndrome and necrotizing enterocolitis. In studies in adults, and in cell culture experiments, probiotics have improved iron absorption, but this question has never been studied in children.
Relevance:
This study proposes to compare the standard treatment for iron deficiency in children (supplemental iron plus vitamin C) with RLS; to supplemental iron plus vitamin C plus probiotics in a randomized, double-blind randomized controlled trial.
Specific Aims:
To improve the treatment of iron deficiency using oral iron, vitamin C, and probiotics in children with RLS and iron deficiency.
To evaluate the safety and monitor for adverse side effects during treatment with probiotics in children with RLS and iron deficiency.
Research Question:
The research question that this study will address is whether the addition of a specific strain of probiotics (lactobacillus plantarum 299) to the standard treatment of iron deficiency (supplemental iron + Vitamin C) will improve the treatment of iron deficiency. Children with RLS are the study population because RLS is a common diagnosis seen in our sleep center, iron deficiency is a known trigger for RLS, and the current standard of care in the evaluation of patients with RLS is to check serum ferritin level at the time of diagnosis and to treat with supplemental iron if the serum ferritin is < 50 mcg/l. However, the implications of this study go far beyond the treatment of children with RLS and iron deficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Restless Leg Syndrome
Keywords
Iron, Deficiency, Restless, Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
iron 3 mg/kg/day elemental iron FeSO4 up to 45 mg (dose to be determined by PI)
+ vitamin C-250 mg chewable tab
+ probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
iron 3 mg/kg/day elemental iron FeSO4 to 45 mg
+ vitamin C-250 mg chewable tab
+ placebo (identical capsule)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Ferritin and CRP Levels
Time Frame
Collection at Baseline and at 6-weeks
Secondary Outcome Measure Information:
Title
Restless Leg Questionnaire
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Rosen, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30732996
Citation
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.
Results Reference
derived
Learn more about this trial
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
We'll reach out to this number within 24 hrs