No registrations found.
ID
Source
Brief title
Health condition
iron deficiency
iron deficiency anaemia
young healthy children from the Netherlands
Sponsors and support
Intervention
Outcome measures
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);
4. Sex;
5. Ethnicity (European versus non-European);
6. Socioeconomic status;
7. BMI;
8. Attending day-care.
Background 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.
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.
Study objective
Our hypothesis is that the iron status in young healthy children from the Netherlands might be insufficient.
Study design
During insertion of a peripheral intraveneus catheter, 2 cc of whole blood will be collected for analysis of the iron status.
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.
Sportlaan 600
Lieke Uijterschout
Den Haag 2566 MJ
The Netherlands
+31 (0)70 2100000
l.uijterschout@hagaziekenhuis.nl
Sportlaan 600
Lieke Uijterschout
Den Haag 2566 MJ
The Netherlands
+31 (0)70 2100000
l.uijterschout@hagaziekenhuis.nl
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);
7. Hemoglobinopathies;
8. Use of iron supplementation less than 6 weeks prior to operation;
9. Blood transfusion in the last 6 months.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL2516 |
| NTR-old | NTR2634 |
| Other | METC : 2010-284 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |