Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women (INFER 2)

Federal Institute of Technology (ETH) Zurich

Status: Enrolling

Conditions: Iron Deficiency Without Anemia

Treatments: Dietary Supplement: ferrous sulfate 160 mg; Dietary Supplement: ferrous sulfate 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06851130

INFER Study 2

Details and patient eligibility

About

Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin following the administration of a daily iron dose for two months.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low iron stores (SF levels < 30 µg/L),
• no anemia (Hb > 120 g/L)
• no inflammation (CRP < 5 mg/L)
• 18 to 45 years old.
• Body weight <70 kg
• Normal body Mass Index (18.5-26.5 kg/m2)

Exclusion criteria

• Any chronic or acute disease
• Consumption of mineral and vitamin supplements since screening and over the study period
• Blood transfusion, blood donation or significant blood loss over the past 4 months,
• Pregnant or breastfeeding,
• Continuous/long-term use of medication during the whole studies (except for contraceptives)
• Therapeutic iron infusion over the past 6 months,
• Known hypersensitivity or allergy to iron supplements,
• Intention to become pregnant over the course of the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

80 mg

Experimental group

Description:

Daily dose of 80 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).

Treatment:

Dietary Supplement: ferrous sulfate 80 mg

160

Experimental group

Description:

Daily dose of 160 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).

Treatment:

Dietary Supplement: ferrous sulfate 160 mg