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NCT01617044 · ClinicalTrials.gov registry record · Phase 2
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
A Phase 2 study of Iron-deficiency and Restless Leg Syndrome, sponsored by Children's Hospitals and Clinics of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT01617044: Completed Phase 2 study of Iron-deficiency and Restless Leg Syndrome, sponsored by Children's Hospitals and Clinics of Minnesota.
NCT01617044 is a Phase 2 study of Iron-deficiency and Restless Leg Syndrome that has completed, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 61 participants, below the 195-participant average among 16 other Iron-deficiency trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617044, a Phase 2 study of Iron-deficiency and Restless Leg Syndrome, has completed, sponsored by Children's Hospitals and Clinics of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Probiotics
Study Locations (1)
Minnesota
- Children's Hospitals and Clinics of Minnesota - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01617044
The ClinicalTrials.gov registry entry for NCT01617044 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 16 other Iron-deficiency trials with a reported enrollment target (69% lower). The listed sponsor is Children's Hospitals and Clinics of Minnesota, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Iron-deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01617044 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01617044 about?
NCT01617044 is a clinical study titled "Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome". 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 wil...
What is the current status of trial NCT01617044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2012-05. Estimated completion is 2015-11.
What conditions does trial NCT01617044 study?
This clinical trial studies the following conditions: Iron-deficiency, Restless Leg Syndrome.
What interventions are being tested in trial NCT01617044?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotics (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01617044?
This trial is sponsored by Children's Hospitals and Clinics of Minnesota, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01617044 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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