Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses

Jessica Rigutto

Status: Completed

Conditions: Iron Deficiency (Without Anemia)

Treatments: Dietary Supplement: 100mg oral iron dosing; Dietary Supplement: 180mg oral iron dosing; Dietary Supplement: 40mg oral iron dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT06657677

INFER Study 1

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, as well as its protein characteristics, following the administration of a single iron dose

Enrollment: 46 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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 6 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: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 3 patient groups

40 mg

Experimental group

Description:

single dose of 40 mg oral iron

Treatment:

Dietary Supplement: 40mg oral iron dosing

100 mg

Experimental group

Description:

single dose of 100 mg oral iron

Treatment:

Dietary Supplement: 100mg oral iron dosing

180 mg

Experimental group

Description:

single dose of 180 mg oral iron

Treatment:

Dietary Supplement: 180mg oral iron dosing