Clinical trial NCT04301336: Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia
Official title: Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vaso-occlusive Crisis
Sickle Cell Disease
Sickle Cell Anemia in Children
Keywords: omega3
Vaso-occlusive painful crisis
Pediatric sickle cell anemia
comparative effective analysis in VOC
Anti-inflammatory effect of Vit-D
Anti-hemolytic effect of Vit-D
Anti-hyperlipidemia of Vit-D
effect of omega-3 on blood rheology
effect of omega-3 on blood viscosity
Antiaggregation effect of omega-3
Anti-inflammatory effect of statins
Anti-inflammatory effect of zinc supplements
effect of zinc supplements on blood viscosity
effect of zinc supplements on blood rheology
Antiaggregation effect of zinc supplements
pediatric sickle cell disease
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Benisuef university hospital
name: University of Arizona
name: Maternity and Children Hospital, Makkah
First posted: 2020-03-10
Enrollment: 350
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four experimental groups, one control group
Primary purpose: TREATMENT

Brief summary: The aim of the present study is comparing the effectiveness of different treatment regimens for investigating the therapeutic potential for each one in management of Vaso-occlusive pain in pediatric sickle cell disease. In addition, investigators apply the Cost-effectiveness analysis (CEA) as a form of economic analysis that compares the relative costs and outcomes (effects) for different treatment regimens on vaso-occlusive painful crisis.

Detailed description: "Sickle cell disease is an inherited blood disorder characterized by defective hemoglobin (a protein in red blood cells that carries oxygen to the tissues of the body).

Sickle cell disease involves the red blood cells, or hemoglobin, and their ability to carry oxygen. Normal hemoglobin cells are smooth, round, and flexible, like the letter "O," so they can move through the vessels in our bodies easily. Sickle cell hemoglobin cells are stiff and sticky and form into the shape of a sickle, or the letter "C," when they lose their oxygen. These sickle cells tend to cluster together and cannot easily move through the blood vessels. The cluster causes a blockage in small arteries or capillaries and stops the movement of healthy, normal oxygen-carrying blood. This blockage is what causes the painful and damaging complications of sickle cell disease".

"Acute vaso-occlusive crisis (VOC) is a hallmark of sickle cell disease (SCD). Multiple complex pathophysiological processes can result in pain during a VOC. Despite significant improvements in the understanding and management of SCD, little progress has been made in the management of pain in SCD, although new treatments are being explored".

The Painful Episodes:

"The day-to-day management of sickle cell disease often equates with the management of acute and chronic pain. Patients manage many painful events at home so that hospital visits underestimate the frequency of pain

Acute painful episodes are the most commonly encountered vaso-occlusive events in patients of all ages. Presumed to be caused by sickle vaso-occlusion, pain often starts in young children as the hand-foot syndrome or dactylitis, a painful swelling of hands and feet due to inflammation of the metacarpal and metatarsal periosteum. Painful episodes, which last from hours to many days, usually occur with little warning and a clear precipitating event is not often found.

Eligibility criteria: Inclusion Criteria:

Any case with the full manifestation of sickle cell disease accompanied by acute painful crisis aged from 5-15 years old.

Exclusion Criteria:

1. The presence of any other chronic illness.
2. Patient age\>18 years old or \< 3 years old.
3. Patients with hepatic diseases including cholestasis hepatic encephalopathy and jaundice.
4. Patients with renal impairment
5. Diabetic patients

Primary outcomes:
measure: C-reactive protein mg/L
timeFrame: 10 months
measure: Hematocrit %
timeFrame: 10 months
measure: Fibrinogen mg/dl
timeFrame: 10 months
measure: Total cholesterol Mg/dl
timeFrame: 10 months
measure: HDL cholesterol Mg/dl
timeFrame: 10 months
measure: LDL cholesterol Mg/dl
timeFrame: 10 months
measure: Triglycerides Mg/dl
timeFrame: 10 months
measure: leukocytes count μl
timeFrame: 10 months
measure: hemoglobin (Hbg) g/dL
timeFrame: 10 months
measure: White blood cells count
timeFrame: 10 months
measure: Lactic acid dehydrogenase U/L
timeFrame: 10 months
measure: Reticulocyte count %
timeFrame: 10 months
measure: Red blood cell (erythrocyte ) sedimentation rate mm/hr
timeFrame: 10 months
measure: lymphocyte count µL
timeFrame: 10 months
measure: Granulocyte absolute count cells/microliter
timeFrame: 10 months
measure: Granulocytes,percentage (GR, pct)
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of medicine, Beni-suef univeristy - Beni-Seuf university hospital
city: Banī Suwayf
country: Egypt
facility: Faculty of Pharmacy, Beni-Suef university
city: Banī Suwayf
country: Egypt
facility: Health insurance hospital
city: Mecca
country: Saudi Arabia
facility: Maternity and Children hospital
Study officials:
affiliation: University of Arizona, College of Pharmacy
name: John E. Murphy [Professor of Pharmacy Practice and Science], PharmD
role: STUDY_DIRECTOR
affiliation: Beni-Suef University, Faculty of medicine
name: Mohamed H Meabad [Prof of Pediatrics], M.D
role: STUDY_DIRECTOR
affiliation: Beni-Suef University, Faculty of medicine
name: AHMED A ALBERRY [Assistant prof of clinical pharmacology], M.D
role: STUDY_DIRECTOR
affiliation: Beni-Suef University, Faculty of Pharmacy
name: RAGHDA R SAYED [Lecturer of Clinical Pharmacy, Ph.D.
role: STUDY_DIRECTOR
affiliation: Beni-Suef University, Faculty of Pharmacy
name: Shaimaa M Nashat Sayed Abdelhalim, Ph.D Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Beni-Suef Health insurance hospital
name: Ahmed F Mahmoud Hussein, MS.c
role: STUDY_DIRECTOR
References: