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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.

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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.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Probiotics

Study Locations (1)

Minnesota

  • Children's Hospitals and Clinics of Minnesota - Saint Paul

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2012-05
Est. Completion 2015-11
Phase Phase 2

What the finished NCT01617044 record still lists

NCT01617044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 195-participant average among 16 other Iron-deficiency trials with a reported enrollment target (69% lower).

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 a single indexed study location in 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.

Similar trials for Iron-deficiency

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01617044's enrollment target sits among peer trials

61 10th of 16 higher than 7 of 16 other Iron-deficiency trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Iron-deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01617044, the US trial registry maintained by the National Library of Medicine. NCT01617044 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.