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

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.

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