Trial · NCT02499354

Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)

NCT02499354, Phase 2, Completed, Auerbach Hematology Oncology Associates P C; results first posted 2023-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA). Trials, record NCT02499354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02499354

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
NCT number: NCT02499354
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Auerbach Hematology Oncology Associates P C
Conditions: Restless Legs Syndrome, Iron Deficiency Anemia
Interventions: Ferumoxytol intravenous, Ferrous sulfate
First posted: 2015-07-16
Last updated: 2024-01-30
Results first posted: 2023-08-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Restless Legs Syndrome Rating Scale	Baseline and at 6 weeks after treatment	Change in International Restless Legs Severity Scale (IRLS) score reflecting RLS severity on the scale of 0-40. The higher the negative score the better the outcome
Primary	Percentage of Participants With Improvement on Clinical Global Impression Scale	Six weeks	Seven questions ranging from Very Much Improved to Very Much Worse: Participant had to be at least Very Much Improved to be considered as having improved. The CGI scale consisted of one question.
Secondary	Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	Up to six weeks	Patient reported gastrointestinal or constitutional adverse events

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Restless Legs Syndrome Rating Scale	Baseline and at 6 weeks after treatment	Those participants with baseline data and at 6 weeks	units on a scale	MEAN
PRIMARY	Percentage of Participants With Improvement on Clinical Global Impression Scale	Six weeks	Those participants with data at six weeks	percentage of participants	NUMBER
SECONDARY	Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	Up to six weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Restless Legs Syndrome Rating Scale	Oral Iron	-14.0000	Standard Deviation 9.75	units on a scale
Change From Baseline in the Restless Legs Syndrome Rating Scale	IV Iron	-9.7353	Standard Deviation 8.33	units on a scale
Percentage of Participants With Improvement on Clinical Global Impression Scale	Oral Iron	75		percentage of participants
Percentage of Participants With Improvement on Clinical Global Impression Scale	IV Iron	68		percentage of participants
Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	Oral Iron	22		Participants
Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	IV Iron	11		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Iron	46
Overall Study	STARTED	IV Iron	47
Overall Study	COMPLETED	Oral Iron	45
Overall Study	COMPLETED	IV Iron	47
Overall Study	NOT COMPLETED	Oral Iron	1
Overall Study	NOT COMPLETED	IV Iron	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Oral Iron	8	46
other	Constipation	Gastrointestinal disorders	IV Iron	1	47
other	Diarrhea	Gastrointestinal disorders	Oral Iron	4	46
other	Diarrhea	Gastrointestinal disorders	IV Iron	2	47
other	Mouth Burn	Gastrointestinal disorders	Oral Iron	0	46
other	Mouth Burn	Gastrointestinal disorders	IV Iron	1	47
other	Gastric Irritation	Gastrointestinal disorders	Oral Iron	7	46
other	Gastric Irritation	Gastrointestinal disorders	IV Iron	5	47
other	Arthralgia/myalgia	Musculoskeletal and connective tissue disorders	Oral Iron	3	46
other	Arthralgia/myalgia	Musculoskeletal and connective tissue disorders	IV Iron	4	47

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Iron	0	46
Total, all-cause mortality	IV Iron	0	47
Total, other adverse events	Oral Iron	22	46
Total, other adverse events	IV Iron	11	47
Total, serious adverse events	Oral Iron	0	46
Total, serious adverse events	IV Iron	0	47

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oral Iron vs IV Iron: Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment.	Trial comparisons
Oral Iron vs IV Iron: deaths from any cause	Trial comparisons
Oral Iron vs IV Iron: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02499354

GET https://conductscience.org/api/trials/v1/NCT02499354/registered

API reference For AI assistants