Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Swiss Federal Institute of Technology150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Iron-deficiency Iron Deficiency Anemia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serum Ferritin (SF)

in consecutive day group

Time frame: Day 93

Serum Ferritin (SF)

in alternate day group

Time frame: Day 186

Event rate of GI side effects

in consecutive day group

Time frame: Day 90

Event rate of GI side effects

in alternate day group

Time frame: Day 183

Secondary Outcomes

Hemoglobin (Hb)

Time frame: Day 0

Hemoglobin (Hb)

Time frame: Day 46

Hemoglobin (Hb)

Time frame: Day 90

Hemoglobin (Hb)

Time frame: Day 139

Hemoglobin (Hb)

Time frame: Day 183

Serum Ferritin (SF)

Time frame: Day 0

Serum Ferritin (SF)

Time frame: Day 46

Serum Ferritin (SF)

Time frame: Day 93

Serum Ferritin (SF)

Time frame: Day 139

Serum Ferritin (SF)

Time frame: Day 186