Sickle Cell Anemia (SCA). Sickle-cell disorders
Conditions
Interventions
Intervention 1: Intervention Group: Patients in this group receive capsules containing beetroot extract according to the prescribed dosage. Name of the Substance: Dried beetroot root extract (Beetroot
Sponsors
Bandare-abbas University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 15 Years
Inclusion criteria
Inclusion criteria: Definitive clinical diagnosis of sickle cell anemia based on laboratory tests Age between 1 to 15 years At least two vaso-occlusive crises in the past 12 months Stable renal function (GFR > 60 mL/min/1.73m²) Parental or guardian willingness to participate in the study and signing the written informed consent
Exclusion criteria
Exclusion criteria: Occurrence of an allergy or intolerance to beetroot extract Use of medications that interact with the supplement, such as nitroglycerin Any other chronic disease, such as severe hypertension, that may affect study outcomes Non-adherence to treatment protocols Hospitalization due to a vaso-occlusive crisis in the past 6 months Known hypersensitivity to nitrate or its derivatives Pregnancy or breastfeeding in mothers Emergence of an emergency condition requiring immediate intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity: The level of pain experienced by patients with sickle cell anemia during a vaso-occlusive crisis. Timepoint: Pain intensity is measured at the beginning of the study (before the intervention), 2 hours after receiving the intervention, and at the end of the hospitalization period. Method of measurement: Pain intensity is measured using the Visual Analog Scale (VAS), a validated measurement tool. The VAS consists of a 10 cm horizontal line, with its two endpoints labeled as "no pain" and "worst pain imaginable," respectively. Patients mark the point on the scale that corresponds to their perceived pain intensity, and the recorded pain level is quantified in centimeters or millimeters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization duration: The number of days a patient remains hospitalized following the occurrence of a vaso-occlusive crisis. Timepoint: At the beginning of the study (before the intervention) or at the time of hospitalization initiation, and at the end of the hospitalization period or at the time of patient discharge. Method of measurement: This variable will be extracted from hospital records and documented in data collection forms. Measurement Tool: Checklist.;Frequency of hospital visits: The number of times a patient visits the hospital due to a vaso-occlusive crisis and requires hospitalization or medical services during the follow-up period. Timepoint: (Before the intervention): The number of hospital visits in the six months prior to the intervention will be recorded, followed by the number of visits throughout the study period. Method of measurement: Data will be extracted from hospital records and patients' medical reports and recorded in electronic data collection forms. Measurement Tool: Checklist.;Serum ferritin level: The concentration of ferritin as an indicator of iron stores in the body of patients with sickle cell anemia, measured in nanograms per milliliter (ng/mL). Timepoint: Serum ferritin levels will be measured at the beginning of the study (before the intervention) and at the end of the study to compare changes in ferritin levels. Method of measurement: Serum Ferritin Test using the Enzyme-Linked Immunoassay (ELISA) or Chemiluminescence method. Measurement Tool: ELISA.;Systolic and diastolic blood pressure: The pressure exerted on the arterial walls during two phases: systole (heart contraction) and diastole (heart relaxation), serving as an indicator of the intervention's effect on blood pressure regulation in patients. Timepoint: Blood pressure will be measured at the beginning of the study (before the intervention), 2 hours after the intervention to assess short-term effects, and at the end of the study (at the time of discharge). Metho | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMona Rahimi
Bandare-abbas University of Medical Sciences
Outcome results
None listed