Investigation of the short-term increase in serum ferritin after oral iron supplementation: An experimental study in women with iron deficiency.
Résumé de l'étude
The most common biomarker for diagnosing iron deficiency is the serum or plasma concentration of the iron storage protein ferritin. In a healthy subject without inflammation or prior iron supplementation, the concentration of serum ferritin (SF) is directly proportional to the body's iron stores. The WHO recommends using SF as the primary biomarker to measure the response to iron supplementation. However, SF acutely increases immediately after oral intake of iron preparations, and this effect is likely independent of the actual total body iron stores. This effect may influence the use of SF as a biomarker during iron supplementation. If measured during or shortly after iron supplementation, this temporary increase in SF may indicate a greater benefit of oral iron supplementation than is actually the case. Furthermore, the ferritin concentration changes in inflammation, as ferritin is an acute phase protein (APP), which can further complicate the determination of iron status.
(BASEC)
Intervention étudiée
The aim of this study is to determine how long the acute increase in SF lasts before the value returns to a level that represents the actual iron stores. This is relevant as a specific SF is often targeted as a treatment goal during supplementation. Measuring SF during or shortly after iron supplementation may lead to premature cessation of supplementation before iron stores are fully replenished. Study 1: Single administration of a stable iron isotope-enriched oral iron dose: 40 mg, 100 mg, or 180 mg, depending on the study group. Assignment to study groups is done randomly. Blood samples on study days 0-7 and 14. A subgroup of the study population also receives the influenza and DTP vaccine with additional blood samples on study days 15-21 and 28. Study 2: Daily intake of oral iron for 2x30 days: 40 mg or 100 mg, depending on the study group. Assignment to study groups is done randomly. Blood samples on study days 1, 3, 6, 10, 20, 30-37, 47, 57, 67-74.
(BASEC)
Maladie en cours d'investigation
Iron deficiency
(BASEC)
All women who: • are aged between 18-45 years. • have a serum ferritin level below 30 µg/L. • have a body weight of up to 70 kg. • have a normal Body Mass Index (weight [kg] / (height [m])² = 18.5 – 25). • have signed the written informed consent. (BASEC)
Critères d'exclusion
Women who may not participate are those who: • have a hemoglobin level below 12 g/dl (measured at the preliminary examination; for definition see page 13). • have a CRP above 5 mg/L (measured at the preliminary examination; for definition see page 13). • suffer from acute or chronic diseases that affect iron absorption and metabolism. • are on long-term medication that affects iron absorption and metabolism and intestinal physiology. • have allergies or hypersensitivities to iron preparations (ferrous fumarate, sodium dodecyl sulfate, brilliant blue FCF (E133), titanium dioxide (E171)). • have taken vitamin or mineral supplements throughout the study (since the preliminary examination). • have difficulties with blood sampling. • have had a blood transfusion, blood donation, or significant blood loss (accident, surgery) in the last 6 months. • are pregnant or breastfeeding or intend to become pregnant during the study period (approximately 1 week from the preliminary examination to the last blood sample). • abuse alcohol or drugs. • smoke (> 1 cigarette per week). • cannot follow the study requirements, e.g., due to language barriers or inability to attend a study appointment. • are study staff, their family members, employees, or other dependent persons. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Prof. Nicole Stoffel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Gianno Rosalen
+41 44 655 74 16
giantizio.rosalen@clutterhest.ethz.chETH
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
10.09.2024
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Assessing the immediate increase in serum ferritin after oral iron doses: an experimental study in iron-deficient women (INFER) (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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