Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Not Applicable

Completed

• Conditions: Iron-deficiency; Iron Deficiency Anemia
• Interventions: Dietary Supplement: Consecutive Day Dosing; Dietary Supplement: Alternate Day Dosing

• Registration Number: NCT05105438
• Lead Sponsor: Swiss Federal Institute of Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-03
• Study Start: 2021-12-16
• Primary Completion: 2022-08-10
• Study Completion: 2022-12-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Consecutive Day Dosing	Consecutive Day Dosing	100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
Alternate Day Dosing	Alternate Day Dosing	100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Primary Outcome Measures

Name	Time	Method
Event rate of GI side effects	Day 183	in alternate day group
Serum Ferritin (SF)	Day 186	in alternate day group

Secondary Outcome Measures

Name	Time	Method
Total iron binding capacity (TIBC)	Day 186
Severity of GI side effects	Day 183
Fecal blood losses	Day 183
Serum Iron (SFe)	Day 186
Hemoglobin (Hb)	Day 183
Serum Ferritin (SF)	Day 186
Serum Transferrin Receptor (sTfR)	Day 186
Calprotectin	Day 183
Event rate of GI side effects	Day 183
Event proportion of GI side effects	Day 183
Iron absorption from supplements	Day 183
C-Reactive Protein (CRP)	Day 186
Alpha-1-acid Glycoprotein (AGP)	Day 186
Intestinal Fatty Acid-binding Protein (I-FABP)	Day 183
Hepcidin	Day 183
Incidence of GI side effects	Day 183

Trial Locations

Locations (1)

ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health; 🇨🇭 Zürich, Switzerland