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Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Consecutive Day Dosing
Alternate Day Dosing
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency focused on measuring iron supplementation, dosing regimen, iron sulfate, women of reproductive age

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Consecutive Day Dosing

Alternate Day Dosing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum Ferritin (SF)
in consecutive day group
Serum Ferritin (SF)
in alternate day group
Event rate of GI side effects
in consecutive day group
Event rate of GI side effects
in alternate day group

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2021
Last Updated
June 9, 2022
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05105438
Brief Title
Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women
Official Title
Comparing Oral Iron Supplementation Using Alternate-day Dosing to the Standard of Care Consecutive-day Dosing in Iron-depleted Women With or Without Mild Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia
Keywords
iron supplementation, dosing regimen, iron sulfate, women of reproductive age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blinded randomized controlled study: participants and investigators are blinded
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Consecutive Day Dosing
Arm Type
Active Comparator
Arm Description
100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
Arm Title
Alternate Day Dosing
Arm Type
Experimental
Arm Description
100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Consecutive Day Dosing
Intervention Description
100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alternate Day Dosing
Intervention Description
100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.
Primary Outcome Measure Information:
Title
Serum Ferritin (SF)
Description
in consecutive day group
Time Frame
Day 93
Title
Serum Ferritin (SF)
Description
in alternate day group
Time Frame
Day 186
Title
Event rate of GI side effects
Description
in consecutive day group
Time Frame
Day 90
Title
Event rate of GI side effects
Description
in alternate day group
Time Frame
Day 183
Secondary Outcome Measure Information:
Title
Hemoglobin (Hb)
Time Frame
Day 0
Title
Hemoglobin (Hb)
Time Frame
Day 46
Title
Hemoglobin (Hb)
Time Frame
Day 90
Title
Hemoglobin (Hb)
Time Frame
Day 139
Title
Hemoglobin (Hb)
Time Frame
Day 183
Title
Serum Ferritin (SF)
Time Frame
Day 0
Title
Serum Ferritin (SF)
Time Frame
Day 46
Title
Serum Ferritin (SF)
Time Frame
Day 93
Title
Serum Ferritin (SF)
Time Frame
Day 139
Title
Serum Ferritin (SF)
Time Frame
Day 186
Title
Serum Transferrin Receptor (sTfR)
Time Frame
Day 0
Title
Serum Transferrin Receptor (sTfR)
Time Frame
Day 46
Title
Serum Transferrin Receptor (sTfR)
Time Frame
Day 93
Title
Serum Transferrin Receptor (sTfR)
Time Frame
Day 139
Title
Serum Transferrin Receptor (sTfR)
Time Frame
Day 186
Title
Total iron binding capacity (TIBC)
Time Frame
Day 0
Title
Total iron binding capacity (TIBC)
Time Frame
Day 93
Title
Total iron binding capacity (TIBC)
Time Frame
Day 186
Title
Serum Iron (SFe)
Time Frame
Day 0
Title
Serum Iron (SFe)
Time Frame
Day 93
Title
Serum Iron (SFe)
Time Frame
Day 186
Title
C-Reactive Protein (CRP)
Time Frame
Day 0
Title
C-Reactive Protein (CRP)
Time Frame
Day 46
Title
C-Reactive Protein (CRP)
Time Frame
Day 93
Title
C-Reactive Protein (CRP)
Time Frame
Day 139
Title
C-Reactive Protein (CRP)
Time Frame
Day 186
Title
Alpha-1-acid Glycoprotein (AGP)
Time Frame
Day 0
Title
Alpha-1-acid Glycoprotein (AGP)
Time Frame
Day 46
Title
Alpha-1-acid Glycoprotein (AGP)
Time Frame
Day 93
Title
Alpha-1-acid Glycoprotein (AGP)
Time Frame
Day 139
Title
Alpha-1-acid Glycoprotein (AGP)
Time Frame
Day 186
Title
Intestinal Fatty Acid-binding Protein (I-FABP)
Time Frame
Day 0
Title
Intestinal Fatty Acid-binding Protein (I-FABP)
Time Frame
Day 90
Title
Intestinal Fatty Acid-binding Protein (I-FABP)
Time Frame
Day 183
Title
Calprotectin
Time Frame
Day 0
Title
Calprotectin
Time Frame
Day 90
Title
Calprotectin
Time Frame
Day 183
Title
Hepcidin
Time Frame
Day 0
Title
Hepcidin
Time Frame
Day 46
Title
Hepcidin
Time Frame
Day 90
Title
Hepcidin
Time Frame
Day 139
Title
Hepcidin
Time Frame
Day 183
Title
Event rate of GI side effects
Time Frame
Day 90
Title
Event rate of GI side effects
Time Frame
Day 183
Title
Incidence of GI side effects
Time Frame
Day 90
Title
Incidence of GI side effects
Time Frame
Day 183
Title
Event proportion of GI side effects
Time Frame
Day 90
Title
Event proportion of GI side effects
Time Frame
Day 183
Title
Severity of GI side effects
Time Frame
Day 90
Title
Severity of GI side effects
Time Frame
Day 183
Title
Fecal blood losses
Time Frame
Day 0
Title
Fecal blood losses
Time Frame
Day 90
Title
Fecal blood losses
Time Frame
Day 183
Title
Iron absorption from supplements
Time Frame
Day 90
Title
Iron absorption from supplements
Time Frame
Day 183

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna von Siebenthal, MSc
Phone
+41 44 632 53 73
Email
hanna.vonsiebenthal@hest.ethz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Stoffel, PhD
Phone
+41 44 632 83 93
Email
nicole.stoffel@hest.ethz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Stoffel, Dr.
Organizational Affiliation
Human Nutrition Laboratory, ETH Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health
City
Zürich
ZIP/Postal Code
8092
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna von Siebenthal, MSc
Phone
+41 44 632 53 73
Email
hanna.vonsiebenthal@hest.ethz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

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