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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome-A Double-blind, Randomized Controlled Study

Conditions
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Iron Deficiency, Restless Leg Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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) | Dietary Supplement: Probiotics<br>* probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)<br>|
| Placebo Comparator: Control<br>iron 3 mg/kg/day elemental iron FeSO4 to 45 mg + vitamin C-250 mg chewable tab + placebo (identical capsule) | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ferritin and CRP Levels |  | Collection at Baseline and at 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restless Leg Questionnaire |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron, Deficiency, Restless, Leg