Clinical trial NCT01617044: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency
Restless Leg Syndrome
Keywords: Iron
Deficiency
Restless
Leg
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 61
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. To improve the treatment of iron deficiency using oral iron, vitamin C, and probiotics in children with RLS and iron deficiency.
2. 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.

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

Primary outcomes:
measure: Change in Ferritin and CRP Levels
timeFrame: Collection at Baseline and at 6-weeks
Secondary outcomes:
measure: Restless Leg Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Gerald Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.