Iron Deficiency AnemiaPhase 4NCT05007899
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
A Phase 4 study testing Ferrous sulfate in people with Iron Deficiency Anemia and Heavy Menstrual Bleeding, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Heavy Menstrual Bleeding, Abnormal Uterine Bleeding
- What is being tested?
- Ferrous sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 22 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 9 years or greater and less than age 22 years
- Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
- Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.
Who cannot join
- non-uterine cause of vaginal bleeding
- pregnancy
- chronic kidney disease
- serology confirmed celiac disease
- active gastrointestinal blood loss
- active malignancy
Show all 9Show fewer
- inability to follow-up at Texas Children's Hospital
- receipt of intravenous iron within 30 days prior to enrollment
- allergy or known inability to tolerate oral iron
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Pavilion for Women
Houston, Texas, 77030
About this study
Official title: Alternate Day Versus Daily Oral Iron Therapy in Adolescents With Iron Deficiency Anemia and Heavy Menstrual Bleeding: A Feasibility Trial
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.
Read the detailed description
The research will be conducted at the following location(s):
Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's Hospital Clinic.
If patient appears to qualify for the study they will sign and date this consent form, and the doctor will confirm that they are eligible for the study. The patient will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Physical Examination
- Blood samples: The patient will not have any extra blood draws (pokes) for this study. However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an extra research test when you have follow up blood test(s) in one month.
Patient will be on the study for 24 weeks (6 months),and will receive an information sheet about how to take iron to help it absorb in the stomach and on iron-rich foods.
There are 2 different treatments in this study. If a patient enrolls, they cannot choose which treatment to receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a fifty percent chance they will receive iron medicine to take every day and a fifty percent chance they will receive iron medicine to take every other day.
- Being tested
- Ferrous sulfate
- Medical subject headings
- Anemia, Iron-Deficiency, Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Also called Fer-In-Sol, Feratab, Iron, Feosol
Alternate day dosing of ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| Daily | Active comparator | Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. Receives: Drug: Ferrous sulfate |
| Alternate Day | Experimental | Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients Enrolled.
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.
Measured: At enrollment
Secondary outcomes (3)
Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization
Percentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log.
Measured: At enrollment
Retention as Measured by Visit Follow-up Adherence
Percentage of enrolled patients that completed 12 weeks of the study.
Measured: 12 weeks
Adherence
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.
Measured: 12 week study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start21 Dec 2020
- Primary completion30 Jun 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacquelyn Powers, MD, MS, Baylor College of Medicine
- Investigators
- Jacquelyn Powers, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007899
- Sponsor's protocol ID
- H - 46363
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2021
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Day Versus Daily Oral Iron Therapy in Adolescents With Iron Deficiency Anemia and Heavy Menstrual Bleeding: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05007899
- Acronym / sponsor ID
- H - 46363
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research will be conducted at the following location(s):
Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's Hospital Clinic.
If patient appears to qualify for the study they will sign and date this consent form, and the doctor will confirm that they are eligible for the study. The patient will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Physical Examination
- Blood samples: The patient will not have any extra blood draws (pokes) for this study. However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an extra research test when you have follow up blood test(s) in one month.
Patient will be on the study for 24 weeks (6 months),and will receive an information sheet about how to take iron to help it absorb in the stomach and on iron-rich foods.
There are 2 different treatments in this study. If a patient enrolls, they cannot choose which treatment to receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a fifty percent chance they will receive iron medicine to take every day and a fifty percent chance they will receive iron medicine to take every other day.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily | Active comparator | Drug: Ferrous sulfatePatients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. |
| Alternate Day | Experimental | Drug: Ferrous sulfatePatients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. |
Who may qualify
- Ages
- 9 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 9 years or greater and less than age 22 years
- Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
- Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.
Key exclusion criteria (9 listed)
- non-uterine cause of vaginal bleeding
- pregnancy
- chronic kidney disease
- serology confirmed celiac disease
- active gastrointestinal blood loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateAlso: Fer-In-Sol, Feratab, Iron, FeosolAlternate day dosing of ferrous sulfate | Drug | Alternate Day, Daily |
Primary outcome
Percentage of Eligible Patients Enrolled.
Time frame: 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.
3 secondary outcomes
Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization
Time frame: At enrollment
Retention as Measured by Visit Follow-up Adherence
Time frame: 12 weeks
Adherence
Time frame: 12 week study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelyn Powers, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous sulfate in people with Iron Deficiency Anemia and Heavy Menstrual Bleeding, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Patients Enrolled. (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.