Vascular Function Intervention Trial in SCD ISRCTN7433141
|ING Staff:||Sharon Cox, Andrew Prentice, Tony Fulford|
This randomised, double blind cross-over trial is designed to test two major endpoints:(1) can a twice daily ready-to-use supplementary food (RUSF) fortified with high levels of the amino acids arginine and citrulline (RUSF-v) plus daily chloroquine syrup improve nitric oxide mediated vascular function in children with SCD; and,
(2) can a twice daily standard RUSF (RUSF-s) with weekly anti-malarial prophylactic chloroquine improve growth in children with SCD.
This intervention is targeted at ameliorating the processes that lead to poor vascular function in SCD and is designed to meet children’s increased nutritional requirements for protein, energy and micronutrients.
Endpoints of the trial:
Primary (>90% power):
- Plasma amino acid profiles
- Plasma arginase activity
- NO-mediated vascular function as assessed using non-invasive ultrasound measurement of flow-mediated dilatation
- Anthropometry using the Tanita Body composition analyser BC418