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van CCT (UK)

van CCT (UK)

Iron status in children with cystic fibrosis.

- candidate number10917
- NTR NumberNTR3231
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2012
- Secondary IDs11-097 
- Public TitleIron status in children with cystic fibrosis.
- Scientific TitleIron status in children with cystic fibrosis.
- hypothesisOur hypothesis is that ID in children with CF is common, and is caused by the combination of an absolute- and a functional-ID, which leads to relative anemia. In this study we will investigate the prevalence and etiology of ID in CF children. Furthermore we expect to find increased sputum iron concentrations in children with CF compared with controls, due to increased hepcidin production.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Iron status, Sputum iron
- Inclusion criteria1. Male and female children, aged 0-18 years;
2. Diagnosed with CF based on accepted clinical criteria; typical clinical history, altered pulmonary function, elevated levels of sodium and chloride in repeated sweat test;
3. Written informed consent from parents/guardian and children themselves if >12 years.
- Exclusion criteriaChildren with a history of haemoptysis within the preceding month are excluded from sputum analysis.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2012
- planned closingdate1-jan-2012
- Target number of participants50
- InterventionsAccording to our actual standard protocol, all children with CF undergo an annual check-up in the Juliana children’s hospital. During this check-up we perform a pulmonary function test in children >6 years and obtain sputum, blood and defecation samples to analyze pulmonary and gastrointestinal status. Parents/caretakers are asked to keep up a food diary for their child for a period of 3 days. In addition to blood sampling as part of the regular check-up, extra blood will be taken to evaluate iron status. In sputum samples obtained during pulmonary function test we will assess iron, ferritin and total cell counts.
- Primary outcomeSerum and sputum iron content.
- Secondary outcome1. Demographics;
2. Pulmonary function test;
3. Dietary information;
4. Clinical severity of disease;
5. Infections;
6. Medication;
7. Anthropometry.
- TimepointsWe estimate iron content in serum and sputum during standard annual check-up.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESDrs. Lieke Uijterschout
- Sponsor/Initiator Juliana Children's Hospital/Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
Juliana Children's Hospital
- PublicationsN/A
- Brief summaryIron deficiency (ID) is common in children and adolescents with cystic fibrosis (CF). Proposed mechanisms for ID in CF may involve absolute ID and/or ID due to chronic inflammation. There are no data on the causes ID in children with CF. Sputum from adult patients with CF contains increased amounts of total iron and ferritin and decreased amounts of transferrin compared with healthy controls. A significant relationship between the iron content of the CF lung microenvironment and the quantitative load of Pseudomonas Aeruginosa (PA) was demonstrated.
The study proposed here will investigate the prevalence and etiology of ID in children with CF. Furthermore we will investigate the sputum iron content in children with CF and the relationship with PA.
- Main changes (audit trail)
- RECORD12-jan-2012 - 2-dec-2013

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