Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04301336 |
|
Recruitment Status :
Completed
First Posted : March 10, 2020
Last Update Posted : January 27, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vaso-occlusive Crisis Sickle Cell Disease Sickle Cell Anemia in Children | Drug: Omega 3 Drug: Vit D Drug: Zinc sulfate Drug: Statins (Cardiovascular Agents) Drug: Hydroxy Urea Drug: Folic Acid Supplementation Drug: Morphine Sulfate Procedure: blood transfusion session | Phase 2 Phase 3 |
"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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Four experimental groups, one control group |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease |
| Actual Study Start Date : | November 1, 2019 |
| Actual Primary Completion Date : | November 1, 2020 |
| Actual Study Completion Date : | December 10, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Omega-3 experimental group
50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. |
Drug: Omega 3
Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months
Other Name: omega-3 supplementation capsules Drug: Hydroxy Urea 50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Other Name: Hydroxy Urea tablet medication 20mg/kg/day Drug: Folic Acid Supplementation Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Other Name: Folic Acid tablet medication 1mg/day Drug: Morphine Sulfate Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
Other Name: Morphine Sulfate intra venous medication Procedure: blood transfusion session Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. |
|
Experimental: Vit-D experimental group
50 patients from each participating hospital that will receive Vit-D medication (1500 IU to 3500 IU ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. |
Drug: Vit D
50 patients from each participating hospital that will receive Vit-D medication (1500 IU to 3500 IU ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. Other Name: Vit-D medication oral drops Drug: Hydroxy Urea 50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Other Name: Hydroxy Urea tablet medication 20mg/kg/day Drug: Folic Acid Supplementation Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Other Name: Folic Acid tablet medication 1mg/day Drug: Morphine Sulfate Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
Other Name: Morphine Sulfate intra venous medication Procedure: blood transfusion session Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. |
|
Experimental: Zinc supplements experimental group
50 patients from each participating hospital that will receive Zinc supplements (15 mg to 50 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. |
Drug: Zinc sulfate
50 patients from each participating hospital that will receive Zinc supplements (15 mg to 50 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. Other Name: Zinc tablet medication Drug: Hydroxy Urea 50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Other Name: Hydroxy Urea tablet medication 20mg/kg/day Drug: Folic Acid Supplementation Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Other Name: Folic Acid tablet medication 1mg/day Drug: Morphine Sulfate Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
Other Name: Morphine Sulfate intra venous medication Procedure: blood transfusion session Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. |
|
Experimental: Statin experimental group
50 patients from each participating hospital that will receive Simvastatin orally (20 mg to 40 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. |
Drug: Statins (Cardiovascular Agents)
50 patients from each participating hospital that will receive Simvastatin orally (20 mg to 40 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved. Other Name: Simvastatin 20mg Drug: Hydroxy Urea 50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Other Name: Hydroxy Urea tablet medication 20mg/kg/day Drug: Folic Acid Supplementation Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Other Name: Folic Acid tablet medication 1mg/day Drug: Morphine Sulfate Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
Other Name: Morphine Sulfate intra venous medication Procedure: blood transfusion session Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. |
|
Active Comparator: Ordinary hospital treatment group
50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months. in addition, Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response in addition, Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose. This group received regular blood transfusion session. |
Drug: Hydroxy Urea
50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Other Name: Hydroxy Urea tablet medication 20mg/kg/day Drug: Folic Acid Supplementation Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Other Name: Folic Acid tablet medication 1mg/day Drug: Morphine Sulfate Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
Other Name: Morphine Sulfate intra venous medication Procedure: blood transfusion session Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. |
- C-reactive protein mg/L [ Time Frame: 10 months ]C-reactive protein milligrams per deciliter
- Hematocrit % [ Time Frame: 10 months ]Hematocrit level in percentage value
- Fibrinogen mg/dl [ Time Frame: 10 months ]Fibrinogen concentration in milligrams per deciliter
- Total cholesterol Mg/dl [ Time Frame: 10 months ]Total cholesterol milligrams per deciliter
- HDL cholesterol Mg/dl [ Time Frame: 10 months ]HDL cholesterol milligrams per deciliter
- LDL cholesterol Mg/dl [ Time Frame: 10 months ]LDL cholesterol milligrams per deciliter
- Triglycerides Mg/dl [ Time Frame: 10 months ]Triglycerides milligrams per deciliter
- leukocytes count μl [ Time Frame: 10 months ]leukocytes in microliter
- hemoglobin (Hbg) g/dL [ Time Frame: 10 months ]hemoglobin (Hbg) gram/deciliter
- White blood cells count [ Time Frame: 10 months ]White blood cells count in a cubic milliliter of blood
- Lactic acid dehydrogenase U/L [ Time Frame: 10 months ]Lactic acid dehydrogenase unit per litter
- Reticulocyte count % [ Time Frame: 10 months ]Reticulocyte count percentage
- Red blood cell (erythrocyte ) sedimentation rate mm/hr [ Time Frame: 10 months ]erythrocyte sedimentation rate in millimeters (mm) per one hour(hr)
- lymphocyte count µL [ Time Frame: 10 months ]lymphocyte count in 1 microliter (µL) of blood
- Granulocyte absolute count cells/microliter [ Time Frame: 10 months ]Granulocyte cells numbers in microliter
- Granulocytes,percentage (GR, pct) [ Time Frame: 10 months ]percentage of white blood cells with granules in percentage
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- The presence of any other chronic illness.
- Patient age>18 years old or < 3 years old.
- Patients with hepatic diseases including cholestasis hepatic encephalopathy and jaundice.
- Patients with renal impairment
- Diabetic patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301336
| Egypt | |
| Faculty of medicine, Beni-suef univeristy - Beni-Seuf university hospital | |
| Banī Suwayf, Egypt | |
| Faculty of Pharmacy, Beni-Suef university | |
| Banī Suwayf, Egypt | |
| Health insurance hospital | |
| Banī Suwayf, Egypt | |
| Saudi Arabia | |
| Maternity and Children hospital | |
| Mecca, Saudi Arabia | |
| Study Director: | John E. Murphy [Professor of Pharmacy Practice and Science], PharmD | University of Arizona, College of Pharmacy | |
| Study Director: | Mohamed H Meabad [Prof of Pediatrics], M.D | Beni-Suef University, Faculty of medicine | |
| Study Director: | AHMED A ALBERRY [Assistant prof of clinical pharmacology], M.D | Beni-Suef University, Faculty of medicine | |
| Study Director: | RAGHDA R SAYED [Lecturer of Clinical Pharmacy, Ph.D. | Beni-Suef University, Faculty of Pharmacy | |
| Principal Investigator: | Shaimaa M Nashat Sayed Abdelhalim, Ph.D Student | Beni-Suef University, Faculty of Pharmacy | |
| Study Director: | Ahmed F Mahmoud Hussein, MS.c | Beni-Suef Health insurance hospital |
| Responsible Party: | SHAIMAA MAHMOUD NASHAT SHAYED ABDELHALIM, Dr.Shaimaa Mahmoud Nashat Sayed Abdelhalim, Ph.D. Researcher and Principal Investigator, Beni-Suef University |
| ClinicalTrials.gov Identifier: | NCT04301336 |
| Other Study ID Numbers: |
Novel TTT of pedia VOC/SCA |
| First Posted: | March 10, 2020 Key Record Dates |
| Last Update Posted: | January 27, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
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 |
|
Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn Zinc Folic Acid Vitamin B Complex Hydroxyurea Morphine Zinc Sulfate Simvastatin Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Trace Elements Micronutrients |