The transferrin saturation/hepcidin radio: a study on the diagnostic value in the differentiation of Iron Refractory Iron Deficiency Anemia from Iron Deficiency Anemia

The transferrin saturation/hepcidin radio: a study on the diagnostic value in the differentiation of Iron Refractory Iron Deficiency Anemia from Iron Deficiency Anemia - SATURNUS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50596

Enrollment

Registered

2017-09-19

Start date

2018-02-07

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Refractory Iron Deficiency Anemia (IRIDA)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion of subjects in the IRIDA group will take place from a population earlier studied by Donker et al, for these subjects clinical data are already available. (Donker et al, Am J Hematol 2016), Inclusion of subjects in the non-IRIDA, iron deficiency anemia group will take place at the gynaecological department (women suffering from menorrhagia) and at the gastrointestinal department (gastrointestinal blood loss and/or malabsorption), the cardiology department, the ER of the Maxima Medical Center IRIDA group In order to be included in this study an IRIDA patient should meet the following criteria: - Previous diagnosis as a mono-allelic or bi-allelic IRIDA patient with an IRIDA phenotype detected after clinical presentation - Presence of microcytic anemia (MCV 18 years o Low TSAT (TSAT

Exclusion criteria

Exclusion criteria: IRIDA group: see above, D4a, inclusions already done, Control group Subjects with the following criteria will not be able to participate in the study because these criteria interfere with the TSAT and hepcidin values. - Pregnancy - Oral iron supplements in the last 3 months before referral to the gynaecologist or gastrointestinal specialist - Diagnosis with any disease associated with inflammation including malignancies, chronic liver and kidney diseases

Design outcomes

Primary

Measure	Time frame
The main study outcome is a cut off point for the TSAT/hepcidin ratio that discriminates IRIDA from iron deficient anemia (IDA) because of other reasons than IRIDA with a high specificity.	—

Secondary

Measure	Time frame
The study will generate data on the mean and interquartile ranges of the TSAT/hepcidin ratio of the IRIDA patients (n=17) and the mean and interquartile ranges of the TSAT/hepcidin ratio of the control group diagnosed with IDA because of other reasons than IRIDA. The data on the TSAT/hepcidin ratios in controls with IDA because of other reasons than IRIDA will be compared with data on TSAT/hepcidin ratios in healthy individuals that have been established earlier in order to determine if there is any difference between these groups (Galesloot et al). Bi-allelic and mono-allelic TMPRSS6 variants may be found in the control patients that have been referred to gastro-enterologist or gynaecologist for analysis of IDA. In these control patients IDA has been incorrectly exclusively attributed to gastrointestinal or gynaecological blood loss and/or malabsorption since IRIDA has not been considered earlier.	—

Measure

Time frame

The study will generate data on the mean and interquartile ranges of the TSAT/hepcidin ratio of the IRIDA patients (n=17) and the mean and interquartile ranges of the TSAT/hepcidin ratio of the control group diagnosed with IDA because of other reasons than IRIDA. The data on the TSAT/hepcidin ratios in controls with IDA because of other reasons than IRIDA will be compared with data on TSAT/hepcidin ratios in healthy individuals that have been established earlier in order to determine if there is any difference between these groups (Galesloot et al). Bi-allelic and mono-allelic TMPRSS6 variants may be found in the control patients that have been referred to gastro-enterologist or gynaecologist for analysis of IDA. In these control patients IDA has been incorrectly exclusively attributed to gastrointestinal or gynaecological blood loss and/or malabsorption since IRIDA has not been considered earlier.

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Countries

Netherlands

Outcome results