|- candidate number||10917|
|- NTR Number||NTR3231|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jan-2012|
|- Secondary IDs||11-097 |
|- Public Title||Iron status in children with cystic fibrosis.|
|- Scientific Title||Iron status in children with cystic fibrosis.|
|- hypothesis||Our 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) studied||Cystic Fibrosis (CF), Iron status, Sputum iron|
|- Inclusion criteria||1. 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 criteria||Children with a history of haemoptysis within the preceding month are excluded from sputum analysis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jan-2012|
|- Target number of participants||50|
|- Interventions||According 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 outcome||Serum and sputum iron content.|
|- Secondary outcome||1. Demographics;|
2. Pulmonary function test;
3. Dietary information;
4. Clinical severity of disease;
|- Timepoints||We estimate iron content in serum and sputum during standard annual check-up. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. Lieke Uijterschout|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Lieke Uijterschout|
|- Sponsor/Initiator ||Juliana Children's Hospital/Haga Hospital|
(Source(s) of Monetary or Material Support)
|Juliana Children's Hospital|
|- Brief summary||Iron 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)|
|- RECORD||12-jan-2012 - 2-dec-2013|