CompletedNot Applicable

Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Switzerland150 participantsStarted 2021-12-16

Plain-language summary

Iron deficiency (ID) with or without anemia is a major public health problem worldwide, especially in women of reproductive age. Iron supplementation can be an effective strategy to prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving oral iron every other day would be an optimized dosing regimen with maximized absorption and a lower incidence of gastrointestinal side effects compared to consecutive day dosing. Long-term trials in which participants and investigators are blinded to the dosing interval with iron status and gastrointestinal side effects as study outcomes are needed.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female, 18 to 45 years old, * SF levels \<25 μg/L, * Hb levels ≥ 11 g/dL * Normal Body Mass Index (18.5-25 kg/m2), * In possession of a mobile phone on which the study app can be loaded, * Signed informed consent, * Not mandatory (only for subgroup analysis): having participated in a former stable iron isotope study in our laboratory between 1-5 y ago Exclusion Criteria: * Elevated CRP \> 5 mg/L, * Any metabolic, gastrointestinal, kidney or chronic disease (self-reported) affecting iron metabolism, * Continuous/long-term use of medication, which may interfere with iron absorption, gut physiology and iron metabolism, * Consumption of additional iron supplements over the study period, * Consumption of iron supplements since screening, * Difficulties with blood sampling, * Known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica) * Pregnancy, breastfeeding * Women who intend to become pregnant during the course of the study, * Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse, * Smokers (\> 1 cigarette per week), * Participant is likely to be absent on one the study appointments, * Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum Ferritin (SF)

Timeframe: Day 93

Serum Ferritin (SF)

Timeframe: Day 186

Event rate of GI side effects

Timeframe: Day 90

Event rate of GI side effects

Timeframe: Day 183

Trial details

NCT IDNCT05105438

SponsorSwiss Federal Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-10

View on ClinicalTrials.gov More Iron-deficiency trials