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

Iron Deficiency Clinical Trial

Official title:

Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome-A Double-blind, Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617044
• Other study ID #: Probiotics_Iron Defieciency
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2012
• Last updated: January 19, 2016
• Start date: May 2012
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Probiotics
probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ferritin and CRP Levels		Collection at Baseline and at 6-weeks	Yes
Secondary	Restless Leg Questionnaire		Baseline	No