Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2022-12-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Iron-deficiency Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blinded randomized controlled study: participants and investigators are blinded

Study Groups

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Consecutive Day Dosing

100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.

Group Type ACTIVE_COMPARATOR

Consecutive Day Dosing

Intervention Type DIETARY_SUPPLEMENT

100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.

Alternate Day Dosing

100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Group Type EXPERIMENTAL

Alternate Day Dosing

Intervention Type DIETARY_SUPPLEMENT

100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Interventions

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Consecutive Day Dosing

100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.

Intervention Type DIETARY_SUPPLEMENT

Alternate Day Dosing

100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes