|- candidate number||8719|
|- NTR Number||NTR2634|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-dec-2010|
|- Secondary IDs||2010-284 METC|
|- Public Title||Irostat.|
|- Scientific Title||Descriptive study to evaluate the iron status in young healthy children from the Netherlands.|
|- hypothesis||Our hypothesis is that the iron status in young healthy children from the Netherlands might be insufficient. |
|- Healt Condition(s) or Problem(s) studied||Iron deficiency , Anemia, Children, Healthy subjects|
|- Inclusion criteria||1. Male and female subjects, aged 6-36 months undergoing elective surgery;|
2. General anesthaesia induced by intravenous injection;
3. Stable health status and expected to remain stable;
4. Written informed consent from parents/guardian.
|- Exclusion criteria||1. Known infection in the last 4 weeks;|
2. Oncologic disorder;
3. Acute or chronic illness;
4. Congenital malformations;
5. Chronic or inhereted metabolic disease;
6. Premature at birth (<32 weeks);
8. Use of iron supplementation less than 6 weeks prior to operation;
9. Blood transfusion in the last 6 months.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-jan-2013|
|- Target number of participants||800|
|- Interventions||During insertion of a peripheral intraveneus catheter, 2 cc of whole blood will be collected for analysis of the iron status. Demographic, dietary and medical information will be collected.|
|- Primary outcome||1. Iron status;|
2. Serum haemoglobin;
3. Mean cell volume and serum ferritin;
4. Reticulocyte hemoglobin content.
|- Secondary outcome||To define whether following factors contribute to iron deficiency during childhood:|
1. Iron status at birth (maternal iron status/anaemia, smoking during pregnancy, preeclampsia, lower gestational age and lower birth weight);
2. Postnatal needs for iron (more rapid growth);
3. Bioavailable iron (more cow milk);
5. Ethnicity (European versus non-European);
6. Socioeconomic status;
8. Attending day-care.
|- Timepoints||During insertion of a peripheral intraveneus catheter, 2 cc of whole blood will be collected for analysis of the iron status. |
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. Lieke Uijterschout|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Hans Goudoever, van|
|- Sponsor/Initiator ||Haga Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale:|
No data are available about the iron status of children in the Netherlands. Recently a large food consumption survey showed low iron intake among these children. Our hypothesis is that the iron status in young healthy children from the Netherlands might be insufficient.
To assess the iron status in young healthy children living in the Netherlands.
National, multi centre, descriptive, observational study.
Healthy children living in the Netherlands aged 0,5-3 years old undergoing elective surgery.
During insertion of a peripheral intraveneus catheter, 2 cc of whole blood will be collected for analysis of the iron status. Demographic, dietary and medical information will be collected.
Main study parameters/endpoints:
Serum haemoglobin, mean cell volume and serum ferritin and reticulocyte hemoglobin content.
|- Main changes (audit trail)||13-Feb-2013: Additional information - NM|
In the same blood sample obtained for assessment of the iron status we additionally assessed hepcidin and transferrin receptor to get more insight in the iron status.
Results of the planned interim analysis conducted after inclusion of 400 children showed a 2,5 times higher prevalence of iron deficiency than expected and therefore we reached sufficient power to answer the studies aim. Consequently, inclusion of more children into the study was not necessary.
|- RECORD||2-dec-2010 - 13-feb-2013|