Clinical trial NCT05414474: Effects of Enhancers and Inhibitors on Absorption From Iron Supplements
Official title: Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Keywords: iron supplementation
women of reproductive age
iron absorption enhancers
iron absorption inhibitors
ferrous fumarate
iron deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.


Eligibility criteria: Inclusion Criteria:

* Female, 18 to 45 years old,
* SF levels \<30 μg/L,
* Body weight \< 70 kg
* Normal Body Mass Index (18.5-25 kg/m2),
* Signed informed consent.

Exclusion Criteria:

* Anemia (Hb \< 12 g/dL)
* Elevated CRP \> 5 mg/L,
* Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
* Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
* Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
* Difficulties with blood sampling,
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
* Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
* 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: Fractional iron absorption [percent]
timeFrame: Day 22
measure: Fractional iron absorption [percent]
timeFrame: Day 43
measure: Total iron absorption [mg]
timeFrame: Day 22
measure: Total iron absorption [mg]
timeFrame: Day 43
Secondary outcomes:
measure: Hemoglobin (Hb)
timeFrame: Day 1, 22, 26 and 43
measure: Serum ferritin (SF)
timeFrame: Day 1, 22, 26 and 43
measure: Serum transferrin receptor (sTfR)
timeFrame: Day 1, 22, 26 and 43
measure: Serum iron (SFe)
timeFrame: Day 1, 22, 26 and 43
measure: Total iron binding capacity (TIBC)
timeFrame: Day 1, 22, 26 and 43
measure: Hepcidin
timeFrame: Day 1, 22 and 26
measure: C-reactive protein (CRP)
timeFrame: Day 1, 22, 26 and 43
measure: Alpha-1-acid-glycoprotein (AGP)
timeFrame: Day 1, 22, 26 and 43
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: