- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617044
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To improve the treatment of iron deficiency using oral iron, vitamin C, and probiotics in children with RLS and iron deficiency.
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
St. Paul, Minnesota, United States, 55102
- Children's Hospitals and Clinics of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
|
Placebo Comparator: Control
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Ferritin and CRP Levels
Time Frame: Collection at Baseline and at 6-weeks
|
Collection at Baseline and at 6-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Restless Leg Questionnaire
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gerald Rosen, MD, Children's Hospitals and Clinics of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Metabolic Diseases
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Hematologic Diseases
- Anemia, Hypochromic
- Anemia
- Iron Metabolism Disorders
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Syndrome
- Psychomotor Agitation
- Restless Legs Syndrome
- Anemia, Iron-Deficiency
Other Study ID Numbers
- Probiotics_Iron Defieciency
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
-
Swiss Federal Institute of TechnologyUniversity of MalawiCompletedIron-deficiency | Iron Deficiency AnemiaMalawi, Switzerland
-
Johann Wolfgang Goethe University HospitalLudwig-Maximilians - University of MunichCompletedNon-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IXIron-deficiency | Anemia | Iron Deficiency AnemiaGermany
-
Kansas State UniversityUnited States Department of Agriculture Foreign Agricultural Service; American...CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Bioavailability | Anemia, Iron Deficiency | Absorption; Iron | Serum IronUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States