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An active new formulation of iron carried by aspartyl casein for iron-deficiency anemia: results of the ACCESS trial.

Annals of hematology
June 1, 2023
Maria Tsilika et al. (7 authors)
Randomized Controlled TrialJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the efficacy and safety of a new oral iron formulation conjugated with N-aspartyl-casein (Fe-ASP) versus ferrous sulfate in treating iron-deficiency anemia.

Results Summary

The study compared Fe-ASP with ferrous sulfate over 12 weeks but did not report specific outcomes regarding Casein's effects in the abstract.

Population

60 patients with iron-deficiency anemia.

Effective Dosage

Twice daily (specific amount not provided).

Duration

12 weeks.

Interactions

None mentioned.

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Oral iron supplementation
neutral
iron-deficiency anemia
-
-
is the cornerstone for the management
#1
A new oral formulation of iron conjugated with N-aspartyl-casein (Fe-ASP) (Omalin®, Uni-Pharma)
neutral
-
60 patients
-
is studied
#2
oral ferrous sulfate (FeSO4)
neutral
-
60 patients
-
-
#3
Abstract

Oral iron supplementation is the cornerstone for the management of iron-deficiency anemia. A new oral formulation of iron conjugated with N-aspartyl-casein (Fe-ASP) (Omalin®, Uni-Pharma) is studied in the ACCESS double-blind, double-dummy randomized clinical trial; 60 patients were randomized to 12-week oral treatment twice every day either with oral ferrous sulfate (FeSO

Medical Subject Headings (MeSH)
HumansIronAnemia, Iron-DeficiencyCaseinsFerritinsHemoglobins
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
0
Research Impact Scores
APT Score0.05
Weight Score2.36
Normalized Score0.67
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