Our hypothesis is that the iron status in young healthy children from the Netherlands might be insufficient.
ID
Bron
Verkorte titel
Aandoening
iron deficiency
iron deficiency anaemia
young healthy children from the Netherlands
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Iron status;<br>
2. Serum haemoglobin;<br>
3. Mean cell volume and serum ferritin;<br>
4. Reticulocyte hemoglobin content.
Achtergrond van het onderzoek
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.
Objective:
To assess the iron status in young healthy children living in the Netherlands.
Study design:
National, multi centre, descriptive, observational study.
Study population:
Healthy children living in the Netherlands aged 0,5-3 years old undergoing elective surgery.
Intervention:
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.
13-02-2013: Additional information:
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.
Doel van het onderzoek
Our hypothesis is that the iron status in young healthy children from the Netherlands might be insufficient.
Onderzoeksopzet
During insertion of a peripheral intraveneus catheter, 2 cc of whole blood will be collected for analysis of the iron status.
Onderzoeksproduct en/of interventie
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.
Publiek
Sportlaan 600
Lieke Uijterschout
Den Haag 2566 MJ
The Netherlands
+31 (0)70 2100000
l.uijterschout@hagaziekenhuis.nl
Wetenschappelijk
Sportlaan 600
Lieke Uijterschout
Den Haag 2566 MJ
The Netherlands
+31 (0)70 2100000
l.uijterschout@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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);
7. Hemoglobinopathies;
8. Use of iron supplementation less than 6 weeks prior to operation;
9. Blood transfusion in the last 6 months.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2516 |
| NTR-old | NTR2634 |
| Ander register | METC : 2010-284 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |