Does BCG (Bacillus of Calmette and Guerin) vaccination of new born babies rapidly reduce their blood level of iron by increasing levels of the hormone hepcidin?
Not Applicable
Completed
- Conditions
- The effect of BCG vaccination on serum iron status in neonatesNeonatal Diseases
- Registration Number
- ISRCTN93854442
- Lead Sponsor
- Medical Research Council (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Neonates seen within the first 24 hours of age
2. Neonates resident in West Kiang, The Gambia and enrolled in the West Kiang Demographic Surveillance System
Exclusion Criteria
1. Neonates with birth weight less than 2000g
2. Neonates with severe birth asphyxia
3. Neonates with major congenital malformations
4. Neonates born to mothers with known HIV or active tuberculosis
5. Neonates born into families with a known active case of tuberculosis in the same compound
6. Neonates currently enrolled in another research study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Plasma transferrin saturation <br>2. Plasma hepcidin level: ELISA - Bachem-25<br>3. Plasma IL-6 level: ELISA<br><br>All outcomes will be measured at baseline (cord blood), <24 hours of age and at either 24 (+/- 4 hours) or 72 hours (+/- 4 hours) from the time of the first venous blood sample. The timing of the second sample (24 or 72 hours) is randomly assigned.
- Secondary Outcome Measures
Name Time Method 1. Serum iron<br>2. Serum Unbound Iron Binding Capacity<br>3. Ferritin<br>4. Transferrin<br>5. Red cell parameters (haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscle haemoglobin concentration, haematocrit, red cell distribution width, red blood cell count) measured by Automated Analyser (Medonic)<br>Iron parameters are measured by Automated Cobas Analyser (Roche).