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

This study is currently recruiting participants.
Verified August 2013 by Children's Hospitals and Clinics of Minnesota
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01617044
First received: March 8, 2012
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Restless Leg Syndrome
Dietary Supplement: Probiotics
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome-A Double-blind, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Change in Ferritin and CRP Levels [ Time Frame: Collection at Baseline and at 6-weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Restless Leg Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Dietary Supplement: Probiotics
probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
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)
Dietary Supplement: Placebo
Placebo

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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617044

Contacts
Contact: Pamual Stading 651-220-6201 pam.stading@childrensmn.org

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Gerald Rosen, MD    651-220-6204    gerald.rosen@childrensmn.org   
Contact: PAMELA J STADING    651-220-6201    pam.stading@childrensmn.org   
Principal Investigator: Gerald Rosen, MD         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Gerald Rosen, MD Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01617044     History of Changes
Other Study ID Numbers: Probiotics_Iron Defieciency
Study First Received: March 8, 2012
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Iron
Deficiency
Restless
Leg

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Anemia, Iron-Deficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014