We aim to determine whether the change in Ret- He, RBC- He and hepcidin concentration to one or two weeks iron supplementation therapy predicts the increase in hemoglobin concentration after 6 weeks of oral iron supplementation therapy in anemic…
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to determine whether the change in Ret- He, RBC- He
and hepcidin concentration from baseline to one or two weeks iron supplemental
therapy predicts the increase in hemoglobin concentration after 6 weeks of oral
iron supplementation therapy;
Secondary outcome
Secondary objectives are to (1) assess the predicting value of Ret- He, RBC- He
and hepcidin concentration at baseline (before therapy) to increase the
hemoglobin concentration after six weeks of oral iron supplementation therapy;
(2) to compare the value of conventional iron status parameters ferritin,
transferrin saturation, soluble transferrin receptor and iron with the novel
iron parameters to predict the response of one, two and six weeks oral iron
supplementation therapy defined by an increase in hemoglobin concentration.
Background summary
Iron deficiency anemia is difficult to assess during inflammatory conditions,
since conventional iron parameters are affected by inflammation. It is
currently unknown which patients benefit from iron supplementation therapy.
However, new iron parameters that offer a functional measure of iron
incorporation have recently become available. These parameters include the iron
incorporation into hemoglobin of reticulocytes (Ret- He)and erythrocytes (RBC-
He) and the iron regulatory hormone hepcidin. A change in these functional iron
parameters to a short course of iron therapy may enable us to study whether
iron is absorbed and incorporated into red blood cells.
Study objective
We aim to determine whether the change in Ret- He, RBC- He and hepcidin
concentration to one or two weeks iron supplementation therapy predicts the
increase in hemoglobin concentration after 6 weeks of oral iron supplementation
therapy in anemic patients with chronic inflammation. Moreover,
we aim to assess whether Ret- He, RBC- He and hepcidin concentration at
baseline (before therapy) a response in hemoglobin concentration after six
weeks of oral iron supplementation therapy. Also, we would like to compare the
value of conventional iron status parameters ferritin, transferrin saturation,
soluble transferrin receptor and iron with the novel iron parameters in
predicting the response of one, two and six weeks oral iron supplementation
therapy.
Study design
The study is designed as an explorative intervention study.
Intervention: Patients will receive ferrous fumarate 200 mg bid during six
weeks.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Venous blood samples will be drawn at four time
points and include one tube of 3 ml and one tube of 8,5 ml. At baseline one
sample includes a standard of care complete blood count of which additional
parameters will be assessed, the other three assessments require an extra
visit, although all efforts will be undertaken to combine this visit with
regular standard of care. Ferrous fumarate is a well tolerated drug with
longstanding experience in usage to treat iron deficiency. The expected adverse
events for this short period of prescription are minor and reversible, and may
include mainly nausea, stomach- ache, diarrhoea or constipation. This study
protocol requires no additional physical examinations, nor questionnaires or
diaries to be filled in.
Geert Grooteplein 8
6500 HB Nijmegen
NL
Geert Grooteplein 8
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
-above 18 years old
-an active chronic inflammatory or infectious disorder with CRP >10 mg/L (defined by the treating medical specialist)
- anemia (defined as hemoglobin concentration below 7.0 mmol/l and 7.5 mmol/l for women and male, respectively).
Exclusion criteria
-not able to take oral medication
-using iron supplements in the previous month
-using erythropoietin
-requiring blood transfusion
-renal and liverfailure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36720.091.11 |