Vaso-occlusive CrisisPhase 2/3NCT04301336
Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia
A Phase 2/3 study testing Omega 3, Vit D and Zinc sulfate in people with Vaso-occlusive Crisis and Sickle Cell Disease, run by Beni-Suef University at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Vaso-occlusive Crisis, Sickle Cell Disease, Sickle Cell Anemia in Children
- What is being tested?
- Omega 3, Vit D and Zinc sulfate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Nov 2019to 10 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any case with the full manifestation of sickle cell disease accompanied by acute painful crisis aged from 5-15 years old.
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Egypt3 sites
Faculty of medicine, Beni-suef univeristy - Beni-Seuf university hospital
Banī Suwayf
Faculty of Pharmacy, Beni-Suef university
Banī Suwayf
Health insurance hospital
Banī Suwayf
About this study
Official title: Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease
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.
Read the 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.
- Being tested
- Omega 3, Vit D, Zinc sulfate, Statins (Cardiovascular Agents), Hydroxy Urea
- 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
- Medical subject headings
- Vaso-Occlusive Crises, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
Also called omega-3 supplementation capsules
Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months
Vit DDrug
Also called Vit-D medication oral drops
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.
Zinc sulfateDrug
Also called Zinc tablet medication
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.
Statins (Cardiovascular Agents)Drug
Also called Simvastatin 20mg
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.
Hydroxy UreaDrug
Also called Hydroxy Urea tablet medication 20mg/kg/day
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.
Folic Acid SupplementationDrug
Also called Folic Acid tablet medication 1mg/day
Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Morphine SulfateDrug
Also called Morphine Sulfate intra venous medication
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.
blood transfusion sessionProcedure or surgery
Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 experimental group | Experimental | 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. Receives: Drug: Omega 3; Drug: Hydroxy Urea; Drug: Folic Acid Supplementation; Drug: Morphine Sulfate; Procedure: blood transfusion session |
| Vit-D experimental group | Experimental | 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. Receives: Drug: Vit D; Drug: Hydroxy Urea; Drug: Folic Acid Supplementation; Drug: Morphine Sulfate; Procedure: blood transfusion session |
| Zinc supplements experimental group | Experimental | 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. Receives: Drug: Zinc sulfate; Drug: Hydroxy Urea; Drug: Folic Acid Supplementation; Drug: Morphine Sulfate; Procedure: blood transfusion session |
| Statin experimental group | Experimental | 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. Receives: Drug: Statins (Cardiovascular Agents); Drug: Hydroxy Urea; Drug: Folic Acid Supplementation; Drug: Morphine Sulfate; Procedure: blood transfusion session |
| Ordinary hospital treatment group | Active comparator | 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. Receives: Drug: Hydroxy Urea; Drug: Folic Acid Supplementation; Drug: Morphine Sulfate; Procedure: blood transfusion session |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein mg/L
C-reactive protein milligrams per deciliter
Measured: 10 months
Hematocrit %
Hematocrit level in percentage value
Measured: 10 months
Fibrinogen mg/dl
Fibrinogen concentration in milligrams per deciliter
Measured: 10 months
Total cholesterol Mg/dl
Total cholesterol milligrams per deciliter
Measured: 10 months
HDL cholesterol Mg/dl
HDL cholesterol milligrams per deciliter
Measured: 10 months
LDL cholesterol Mg/dl
LDL cholesterol milligrams per deciliter
Measured: 10 months
Triglycerides Mg/dl
Triglycerides milligrams per deciliter
Measured: 10 months
leukocytes count μl
leukocytes in microliter
Measured: 10 months
hemoglobin (Hbg) g/dL
hemoglobin (Hbg) gram/deciliter
Measured: 10 months
White blood cells count
White blood cells count in a cubic milliliter of blood
Measured: 10 months
Lactic acid dehydrogenase U/L
Lactic acid dehydrogenase unit per litter
Measured: 10 months
Reticulocyte count %
Reticulocyte count percentage
Measured: 10 months
Red blood cell (erythrocyte ) sedimentation rate mm/hr
erythrocyte sedimentation rate in millimeters (mm) per one hour(hr)
Measured: 10 months
lymphocyte count µL
lymphocyte count in 1 microliter (µL) of blood
Measured: 10 months
Granulocyte absolute count cells/microliter
Granulocyte cells numbers in microliter
Measured: 10 months
Granulocytes,percentage (GR, pct)
percentage of white blood cells with granules in percentage
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Nov 2019
- Primary completion1 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaso-occlusive CrisisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four experimental groups, one control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Benisuef university hospital, University of Arizona, Maternity and Children Hospital, Makkah
- Responsible party
- Principal investigator, SHAIMAA MAHMOUD NASHAT SHAYED ABDELHALIM, Beni-Suef University
- Investigators
- John E. Murphy [Professor of Pharmacy Practice and Science], PharmD, Study director, University of Arizona, College of PharmacyMohamed H Meabad [Prof of Pediatrics], M.D, Study director, Beni-Suef University, Faculty of medicineAHMED A ALBERRY [Assistant prof of clinical pharmacology], M.D, Study director, Beni-Suef University, Faculty of medicineRAGHDA R SAYED [Lecturer of Clinical Pharmacy, Ph.D., Study director, Beni-Suef University, Faculty of PharmacyShaimaa M Nashat Sayed Abdelhalim, Ph.D Student, Principal investigator, Beni-Suef University, Faculty of PharmacyAhmed F Mahmoud Hussein, MS.c, Study director, Beni-Suef Health insurance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301336
- Sponsor's protocol ID
- Novel TTT of pedia VOC/SCA
- Status last verified
- Jan 2021
- First submitted
- 6 Mar 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04301336
- Acronym / sponsor ID
- Novel TTT of pedia VOC/SCA
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Benisuef university hospital, University of Arizona, Maternity and Children Hospital, Makkah
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Four experimental groups, one control group
| Arm | Type | Receives |
|---|---|---|
| Omega-3 experimental group | Experimental | Drug: Omega 3, Drug: Hydroxy Urea, Drug: Folic Acid Supplementation, Drug: Morphine Sulfate, Procedure: blood transfusion session50 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. |
| Vit-D experimental group | Experimental | Drug: Vit D, Drug: Hydroxy Urea, Drug: Folic Acid Supplementation, Drug: Morphine Sulfate, Procedure: blood transfusion session50 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. |
| Zinc supplements experimental group | Experimental | Drug: Zinc sulfate, Drug: Hydroxy Urea, Drug: Folic Acid Supplementation, Drug: Morphine Sulfate, Procedure: blood transfusion session50 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. |
| Statin experimental group | Experimental | Drug: Statins (Cardiovascular Agents), Drug: Hydroxy Urea, Drug: Folic Acid Supplementation, Drug: Morphine Sulfate, Procedure: blood transfusion session50 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. |
| Ordinary hospital treatment group | Active comparator | Drug: Hydroxy Urea, Drug: Folic Acid Supplementation, Drug: Morphine Sulfate, Procedure: blood transfusion session50 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any case with the full manifestation of sickle cell disease accompanied by acute painful crisis aged from 5-15 years old.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Also: omega-3 supplementation capsulesOmega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months | Drug | Omega-3 experimental group |
| Vit DAlso: Vit-D medication oral drops50 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 experimental group |
| Zinc sulfateAlso: Zinc tablet medication50 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 supplements experimental group |
| Statins (Cardiovascular Agents)Also: Simvastatin 20mg50 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 | Statin experimental group |
| Hydroxy UreaAlso: Hydroxy Urea tablet medication 20mg/kg/day50 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. | Drug | Omega-3 experimental group, Ordinary hospital treatment group, Statin experimental group, Vit-D experimental group, Zinc supplements experimental group |
| Folic Acid SupplementationAlso: Folic Acid tablet medication 1mg/dayFolic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response | Drug | Omega-3 experimental group, Ordinary hospital treatment group, Statin experimental group, Vit-D experimental group, Zinc supplements experimental group |
| Morphine SulfateAlso: Morphine Sulfate intra venous medicationMorphine 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. | Drug | Omega-3 experimental group, Ordinary hospital treatment group, Statin experimental group, Vit-D experimental group, Zinc supplements experimental group |
| blood transfusion sessionRegular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. | Procedure or surgery | Omega-3 experimental group, Ordinary hospital treatment group, Statin experimental group, Vit-D experimental group, Zinc supplements experimental group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Related trials for Vaso-occlusive Crisis
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RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Recruiting
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Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E. Murphy [Professor of Pharmacy Practice and Science], PharmD study director
University of Arizona, College of Pharmacy
Mohamed H Meabad [Prof of Pediatrics], M.D study director
Beni-Suef University, Faculty of medicine
AHMED A ALBERRY [Assistant prof of clinical pharmacology], M.D study director
Beni-Suef University, Faculty of medicine
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega 3, Vit D and Zinc sulfate in people with Vaso-occlusive Crisis and Sickle Cell Disease, run by Beni-Suef University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein mg/L (time frame: 10 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.