Development of a ready-to-use nutraceutical food for patients with sickle cell disease: testing of vascular support components

ondon School of Hygiene and Tropical Medicine (UK)0 个研究点目标入组 119 人开始时间: 2012年2月2日最近更新: 2021年1月5日

适应症

试验速览

•1. Aged 8-11 years old at enrolment and resident within urban Dar-es-Salaam
•2. Enrolled in MSC and attending routine MNH sickle clinics
•3. Haemoglobin phenotype SS (HbSS) confirmed by electrophoresis and High-performance liquid chromatography (HPLC)

•1. >95th percentile for body mass index (BMI) for age using British 1990 growth standards
•2. Receiving hydroxyurea (HU) therapy or significant other long-term drug therapy
•3. Diagnosis with clinically significant non-SCD related disease including:
•3.1. Stage III or above human immunodeficiency virus (HIV) ? or receiving antiretroviral therapy (ART) therapy regardless of Acquired immune deficiency syndrome (AIDS) stage
•3.2. Tuberculosis infection
•3.3. Blood transfusion within previous 30 days
•4. Previously diagnosed clinical pulmonary hypertension or cardiac dysfunction or clinical signs of pulmonary hypertension (loud pulmonary second heart sound) or heart failure (displaced apex beat, high jugular venous pressure, enlarged liver, peripheral oedema)
•5. Low visual acuity at baseline (<6/9 using a modified (for Tanzania) Snellen chart or previously diagnosed chronic eye disorder likely to suggest retinopathy or macular degeneration
•6. Significant hepatic/renal dysfunction assessed by clinical chemistry panel at baseline
•7. Epilepsy, psoriasis or currently taking any drugs listed as interacting with chloroquine

发起方

ondon School of Hygiene and Tropical Medicine (UK)