A Phase 2/3 interventional study of Acacia Senegal extract and Pectin in Sickle Cell Anemia in Children, sponsored by Al-Neelain University. Status unknown at 1 site in Sudan. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Al-Neelain University · Phase 2/3, Interventional, and Supportive care
To study the efficacy of Gum Arabic as an anti-oxidant, anti-inflammatory and Fetal Hemoglobin-inducing agent among Sickle Cell Disease children. Half of participants will receive Gum Arabic and the other half will receive placebo
Polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . Fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . Gum Arabic is soluble fibers with prebiotic properties. It increased the level of serum butyrate which is short chain fatty acid. The latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. And also has strong anti-inflammatory properties. So our aim to test whether oral digestion of Gum Arabic will induce fetal hemoglobin among sickle cell pediatric patients
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Al-Neelain University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Subjects whom medications and dosages had been stable for 2 weeks before study entry.
Subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention.
Exclusion Criteria:
Patients who are currently using Gum Arabic. Patients who are on or chemotherapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose for participants above 5 years of age and 15-grams-dose for participants below 5 years of age for 12 weeks
Dietary Supplement: Acacia Senegal extract
This group will be provided with pectin powder provided as one-gram-dose for children below 5 years of age \& two-gram-dose for children above 5 years of age
Dietary Supplement: Pectin
Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
Also known as: (Gum Arabic)
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
Fetal hemoglobin level after 12 weeks
Measure increase from the baseline values
Time frame: 12 weeks
Total anti oxidant capacity
Measure increase from the baseline values
Time frame: 12 weeks
Anti inflammatory marker C reactive Protein
Measure decrease from the baseline values
Time frame: 12 weeks
Plan to share: Undecided — Share patients data without personal data and without breaching confidentiality
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Al-Neelain University