Effects of Enhancers and Inhibitors on Absorption From Iron Supplements

Iron Deficiency Anemia Clinical Trial

Official title:

Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414474
• Other study ID #: IDEA
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 9, 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 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 <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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Reference
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes
• Ascorbic acid (AA) 500 mg
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA
• Ascorbic acid (AA) 80 mg
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA
• Coffee
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee
• Breakfast
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 1 bread roll (~100 g) with butter and honey + 1 cup of plain yoghurt (180 mL) + 1 cup of coffee (150 mL) + 1 glass of orange juice (250 mL)
• Afternoon
Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon

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	Fractional iron absorption [percent]	Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.	Day 22
Primary	Fractional iron absorption [percent]	Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.	Day 43
Primary	Total iron absorption [mg]	Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.	Day 22
Primary	Total iron absorption [mg]	Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.	Day 43
Secondary	Hemoglobin (Hb)	Iron status marker	Day 1, 22, 26 and 43
Secondary	Serum ferritin (SF)	Iron status marker	Day 1, 22, 26 and 43
Secondary	Serum transferrin receptor (sTfR)	Iron status marker	Day 1, 22, 26 and 43
Secondary	Serum iron (SFe)	Iron status marker	Day 1, 22, 26 and 43
Secondary	Total iron binding capacity (TIBC)	Iron status marker	Day 1, 22, 26 and 43
Secondary	Hepcidin	Iron regulatory protein	Day 1, 22 and 26
Secondary	C-reactive protein (CRP)	Inflammation marker	Day 1, 22, 26 and 43
Secondary	Alpha-1-acid-glycoprotein (AGP)	Inflammation marker	Day 1, 22, 26 and 43