In this intervention period children will receive a vascular ready-to-use supplementary food with added L-Arginine & L-Citrulline plus daily chloroquine

In this intervention period children will receive a regular ready-to-use supplementary food plus weekly dose of chloroquine

Sickle Cell Disease

Daily vascular ready-to-use supplementary food containing protein, energy and fortified with 1 x recommended daily allowance(RDA) of vitamins and minerals except for folic acid = 1mg and with no iron fortificant included and fortified with arginine and citrulline amino acids

Vascular ready-to-use supplementary food

Daily ready-to-use supplementary food containing protein, energy and fortified with 1 x RDA vitamins and minerals except for folic acid = 1mg and with no iron fortificant included.

Regular Ready-to-use supplementary food

Chloroquine

Muhimbili University of Heath and Allied Sciences (MUHAS)

Vascular Function Intervention Trial in Sickle Cell Disease

Development of a Ready-to-use Nutraceutical Food for Patients With Sickle Cell Disease (SCD): Testing of Vascular Support Components

We will compare the effects of the RUSFv compared to the simple RUSF on:
The ratio of plasma arginine to ornithine & ratio of arginine to ADMA and adjust for values at baseline
Time frame definition:
0 months = baseline
4 months = after 1st four-month intervention period, before washout 1
8 months = after 1st 4 month washout period before 2nd intervention period
12 months = after 2nd four-month intervention period, before washout 2
16 months = after 2nd 4 month washout period (study end)

Comparison of the effects of the RUSFv to the simple RUSF on vascular function, assessed using flow mediated dilatation (FMDmax), adjusted for baseline values at time 0. Values will also be determined at time point at month 8, in order to check for possible carry-over effect.

We will compare the effects of RUSF compared to no RUSF on rates of growth by comparison of the 2 intervention periods combined with the two washout periods combined, by conducting measurements at months 0, 4, 8, 12 & 16.

Full blood counts (FBC) of ethylenediaminetetraacetic acid (EDTA) whole blood will be conducted

Concentrations of soluble adhesion molecules (VCAM-1, vascular endothelial growth factor-1 (VEGF-1), tumor necrosis factor-alpha (TNF-α) & e-selectin, tissue factor and IL-6) will be measured in frozen (-80⁰C) plasma aliquots.
C-reactive protein concentrations will be measured in frozen serum samples and leukocyte counts from FBC.

Plasma haemoglobin will be measured in frozen serum aliquots. Unconjugated bilirubin and lactate dehydrogenase in fresh serum.

Study personnel will administer detailed questionnaires at weekly home visits to assess the frequency of all sickle and non-sickle associated morbidity and health seeking behaviour, with a focus on painful episodes. Participatory research will be used to determine the likely application and optimal formatting of pain diaries to be completed by patients and families in addition to the standard questionnaire.

aspartate transaminase, alkaline phosphatase, total and direct bilirubin and creatinine will be measured in fresh serum

glomerular filtration rate will be estimated using an adaptation of the Schwartz equation in which muscle mass measured using bioimpedance will be included in the formula instead of the usual estimate. The outcome will be adjusted for values at baseline.

ornithine/moždani udar

Vascular Function Intervention Trial in Sickle Cell Disease

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