NCT05007899

Alternate Day Versus Daily Oral Iron Therapy in Adolescents

Completed Phase 4 Results posted Last updated 13 September 2023

What this trial tests

Phase 4 trial testing Ferrous sulfate in Iron Deficiency Anemia in 13 participants. Completed in 22 December 2022.

Timeline

21 December 2020

Primary endpoint
30 June 2022

22 December 2022

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	13
Start date	21 December 2020
Primary completion	30 June 2022
Estimated completion	22 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Ferrous sulfate — full drug profile →

Conditions studied

• Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
• Heavy Menstrual Bleeding — all drugs for Heavy Menstrual Bleeding →
• Abnormal Uterine Bleeding — all drugs for Abnormal Uterine Bleeding →

Sponsor

Baylor College of Medicine

Who can join

Adults 9 to 22, female only, with Iron Deficiency Anemia or Heavy Menstrual Bleeding. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eligible Patients Enrolled. Primary · At enrollment

Percentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log.

Group	Value	95% CI
All Eligible Patients	13

Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization Secondary · At enrollment

Percentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log.

Group	Value	95% CI
Daily	7
Alternate Day	6

Retention as Measured by Visit Follow-up Adherence Secondary · 12 weeks

Percentage of enrolled patients that completed 12 weeks of the study.

Group	Value	95% CI
Daily	5
Alternate Day	2

Adherence Secondary · 12 week study visit

Pill counts were performed as an objective measure of adherence. Subjects were given a specific number of pills for the duration of the study. At the 12 week visit they were asked to return any remaining pills, which were then counted and compared to the number of expected pills should be remaining, assuming 100% adherence. These numbers were used to calculate an estimate of adherence.

Group	Value	95% CI
Daily	65	31 – 100
Alternate Day	0	0 – 0

Adverse events — posted to ClinicalTrials.gov

Time frame: Twelve weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Daily

Serious: 0/5 (0%)

Deaths: 0/5

Alternate Day

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (4 terms — click to expand)

Reaction	System	Daily	Alternate Day
Heartburn	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT05007899 adverse events section.

Sponsor's own description

Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia.

The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.