Clinical trial NCT05105438: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Keywords: iron supplementation
dosing regimen
iron sulfate
women of reproductive age
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Serum Ferritin (SF)
timeFrame: Day 93
measure: Serum Ferritin (SF)
timeFrame: Day 186
measure: Event rate of GI side effects
timeFrame: Day 90
measure: Event rate of GI side effects
timeFrame: Day 183
Secondary outcomes:
measure: Hemoglobin (Hb)
timeFrame: Day 0
measure: Hemoglobin (Hb)
timeFrame: Day 46
measure: Hemoglobin (Hb)
timeFrame: Day 90
measure: Hemoglobin (Hb)
timeFrame: Day 139
measure: Hemoglobin (Hb)
timeFrame: Day 183
measure: Serum Ferritin (SF)
timeFrame: Day 0
measure: Serum Ferritin (SF)
timeFrame: Day 46
measure: Serum Ferritin (SF)
timeFrame: Day 93
measure: Serum Ferritin (SF)
timeFrame: Day 139
measure: Serum Ferritin (SF)
timeFrame: Day 186
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 0
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 46
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 93
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 139
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 186
measure: Total iron binding capacity (TIBC)
timeFrame: Day 0
measure: Total iron binding capacity (TIBC)
timeFrame: Day 93
measure: Total iron binding capacity (TIBC)
timeFrame: Day 186
measure: Serum Iron (SFe)
timeFrame: Day 0
measure: Serum Iron (SFe)
timeFrame: Day 93
measure: Serum Iron (SFe)
timeFrame: Day 186
measure: C-Reactive Protein (CRP)
timeFrame: Day 0
measure: C-Reactive Protein (CRP)
timeFrame: Day 46
measure: C-Reactive Protein (CRP)
timeFrame: Day 93
measure: C-Reactive Protein (CRP)
timeFrame: Day 139
measure: C-Reactive Protein (CRP)
timeFrame: Day 186
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 0
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 46
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 93
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 139
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 186
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 0
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 90
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 183
measure: Calprotectin
timeFrame: Day 0
measure: Calprotectin
timeFrame: Day 90
measure: Calprotectin
timeFrame: Day 183
measure: Hepcidin
timeFrame: Day 0
measure: Hepcidin
timeFrame: Day 46
measure: Hepcidin
timeFrame: Day 90
measure: Hepcidin
timeFrame: Day 139
measure: Hepcidin
timeFrame: Day 183
measure: Event rate of GI side effects
timeFrame: Day 90
measure: Event rate of GI side effects
timeFrame: Day 183
measure: Incidence of GI side effects
timeFrame: Day 90
measure: Incidence of GI side effects
timeFrame: Day 183
measure: Event proportion of GI side effects
timeFrame: Day 90
measure: Event proportion of GI side effects
timeFrame: Day 183
measure: Severity of GI side effects
timeFrame: Day 90
measure: Severity of GI side effects
timeFrame: Day 183
measure: Fecal blood losses
timeFrame: Day 0
measure: Fecal blood losses
timeFrame: Day 90
measure: Fecal blood losses
timeFrame: Day 183
measure: Iron absorption from supplements
timeFrame: Day 90
measure: Iron absorption from supplements
timeFrame: Day 183
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health
Study officials:
affiliation: Human Nutrition Laboratory, ETH Zuerich
name: Nicole Stoffel, Dr.
role: PRINCIPAL_INVESTIGATOR
References: