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

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ClinicalTrials.gov Identifier: NCT01617044
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

March 8, 2012
June 12, 2012
January 20, 2016
May 2012
November 2015   (Final data collection date for primary outcome measure)
Change in Ferritin and CRP Levels [ Time Frame: Collection at Baseline and at 6-weeks ]
Same as current
Complete list of historical versions of study NCT01617044 on ClinicalTrials.gov Archive Site
Restless Leg Questionnaire [ Time Frame: Baseline ]
Same as current
Not Provided
Not Provided
 
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome-A Double-blind, Randomized Controlled Study
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Iron Deficiency
  • Restless Leg Syndrome
  • Dietary Supplement: Probiotics
    probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
  • Dietary Supplement: Placebo
    Placebo
  • Experimental: Treatment
    1. iron 3 mg/kg/day elemental iron FeSO4 up to 45 mg (dose to be determined by PI)
    2. + vitamin C-250 mg chewable tab
    3. + probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Control
    1. iron 3 mg/kg/day elemental iron FeSO4 to 45 mg
    2. + vitamin C-250 mg chewable tab
    3. + placebo (identical capsule)
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
100
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01617044
Probiotics_Iron Defieciency
No
Not Provided
Not Provided
Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
Not Provided
Principal Investigator: Gerald Rosen, MD Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP