Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
Condition: Iron Deficiency; Restless Leg Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Anemia, Iron-Deficiency; Iron Deficiencies; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotics lactobacillus plantarum 299 (1x10x8 colony forming units); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iron; Deficiency; Restless; Leg