Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

NCT05105438 | Completed DMC

• 1 other identifier: CAPS_CH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia

Keywords

iron supplementation; dosing regimen; iron sulfate; women of reproductive age

Outcome Measures

Primary Outcomes (4)

• Serum Ferritin (SF)

  in consecutive day group

  Day 93

• Serum Ferritin (SF)

  in alternate day group

  Day 186

• Event rate of GI side effects

  in consecutive day group

  Day 90

• Event rate of GI side effects

  in alternate day group

  Day 183

Secondary Outcomes (55)

• Hemoglobin (Hb)

  Day 0

• Hemoglobin (Hb)

  Day 46

• Hemoglobin (Hb)

  Day 90

• Hemoglobin (Hb)

  Day 139

• Hemoglobin (Hb)

  Day 183

Study Arms (2)

Consecutive Day Dosing

ACTIVE COMPARATOR

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

Dietary Supplement: Consecutive Day Dosing

Alternate Day Dosing

EXPERIMENTAL

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

Dietary Supplement: Alternate Day Dosing

Interventions

Consecutive Day Dosing DIETARY_SUPPLEMENT

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

Consecutive Day Dosing

Alternate Day Dosing DIETARY_SUPPLEMENT

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

Alternate Day Dosing

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health

Zurich, 8092, Switzerland

Location

Related Publications (1)

• von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.

  PMID: 38021373 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicole Stoffel, Dr.

  Human Nutrition Laboratory, ETH Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded randomized controlled study: participants and investigators are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: December 16, 2021
• Primary Completion: August 10, 2022
• Study Completion: December 8, 2022
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)