Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105438
• Other study ID #: CAPS_CH
• Status: Completed
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2024
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 8, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

Dietary Supplement:
• Consecutive Day Dosing
100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
• Alternate Day Dosing
100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.

Locations

Country	Name	City	State
Switzerland	ETH Zurich; Human Nutrition Laboratory; Institute of Food, Nutrition and Health	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Ferritin (SF)	in consecutive day group	Day 93
Primary	Serum Ferritin (SF)	in alternate day group	Day 186
Primary	Event rate of GI side effects	in consecutive day group	Day 90
Primary	Event rate of GI side effects	in alternate day group	Day 183
Secondary	Hemoglobin (Hb)		Day 0
Secondary	Hemoglobin (Hb)		Day 46
Secondary	Hemoglobin (Hb)		Day 90
Secondary	Hemoglobin (Hb)		Day 139
Secondary	Hemoglobin (Hb)		Day 183
Secondary	Serum Ferritin (SF)		Day 0
Secondary	Serum Ferritin (SF)		Day 46
Secondary	Serum Ferritin (SF)		Day 93
Secondary	Serum Ferritin (SF)		Day 139
Secondary	Serum Ferritin (SF)		Day 186
Secondary	Serum Transferrin Receptor (sTfR)		Day 0
Secondary	Serum Transferrin Receptor (sTfR)		Day 46
Secondary	Serum Transferrin Receptor (sTfR)		Day 93
Secondary	Serum Transferrin Receptor (sTfR)		Day 139
Secondary	Serum Transferrin Receptor (sTfR)		Day 186
Secondary	Total iron binding capacity (TIBC)		Day 0
Secondary	Total iron binding capacity (TIBC)		Day 93
Secondary	Total iron binding capacity (TIBC)		Day 186
Secondary	Serum Iron (SFe)		Day 0
Secondary	Serum Iron (SFe)		Day 93
Secondary	Serum Iron (SFe)		Day 186
Secondary	C-Reactive Protein (CRP)		Day 0
Secondary	C-Reactive Protein (CRP)		Day 46
Secondary	C-Reactive Protein (CRP)		Day 93
Secondary	C-Reactive Protein (CRP)		Day 139
Secondary	C-Reactive Protein (CRP)		Day 186
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 0
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 46
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 93
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 139
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 186
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 0
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 90
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 183
Secondary	Calprotectin		Day 0
Secondary	Calprotectin		Day 90
Secondary	Calprotectin		Day 183
Secondary	Hepcidin		Day 0
Secondary	Hepcidin		Day 46
Secondary	Hepcidin		Day 90
Secondary	Hepcidin		Day 139
Secondary	Hepcidin		Day 183
Secondary	Event rate of GI side effects		Day 90
Secondary	Event rate of GI side effects		Day 183
Secondary	Incidence of GI side effects		Day 90
Secondary	Incidence of GI side effects		Day 183
Secondary	Event proportion of GI side effects		Day 90
Secondary	Event proportion of GI side effects		Day 183
Secondary	Severity of GI side effects		Day 90
Secondary	Severity of GI side effects		Day 183
Secondary	Fecal blood losses		Day 0
Secondary	Fecal blood losses		Day 90
Secondary	Fecal blood losses		Day 183
Secondary	Iron absorption from supplements		Day 90
Secondary	Iron absorption from supplements		Day 183