Paediatrics
Conditions
Interventions
Intervention name is placebo as uncooked cornstarch
Sponsors
Cairo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 2 y to 13 y. Patients diagnosed with hypercholesterolemia according toSimon Broome FH Register diagnostic criteria Patients diagnosed with hypertriglyceridemia according to Values integrated from National Expert Panel on Blood Cholesterol Levels in Children, the 2011 Expert Panel on Cardiovascular Risk Reduction in Children, and the 2010 Endocrine Society Guidelines
Exclusion criteria
Exclusion criteria: • Lipid apheresis within the last 12 weeks before screening. • Diabetes and newly diagnosed impaired glucose tolerance. • Patients with hypercholesterolemia receiving SC injection of Evolocumab in the form of Repatha (Amgen). • Impaired result of screening laboratory tests: Creatine kinase (CK), AST, ALT, eGFR, TSH and free thyroxine level. • Known illness: o History or evidence of unstable cardiac condition or planned or expected procedure that, in the opinion of the investigator, would pose a risk to patient safety or interfere with study. o Active infection. o Major hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction per the judgment of the investigator. • Presence of any of the following contraindications: o Hypersensitivity to active substances or to other plants of the same family. o Patients who had difficulty in swallowing or any throat problems. Patients suffering from abnormal constrictions or inflammatory illness in the gastro-intestinal tract. o In case of intestinal obstruction, potential or existing intestinal blockage (ileus). o Patients with diseases of the esophagus and cardia. Paralysis of the intestine or megacolon. o Patients experiencing a sudden change in bowel habits that had persisted for more than 2 weeks. o Patients with fecal impact. o Patients with undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in LDL-C (Low-Density Lipoprotein Cholesterol) Reduction in Total Cholesterol Baseline (0 months): This is the pre-intervention measurement, taken before the administration of psyllium husk fiber begins. •3 months: This is a mid-intervention assessment, conducted while participants are still receiving the fiber supplementation. •6 months: This is the post-intervention measurement, taken after completing the full course of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase in HDL-C (High-Density Lipoprotein Cholesterol): Reduction in Triglycerides Summarize Baseline (0 months): This is the pre-intervention measurement, taken before the administration of psyllium husk fiber begins. • 3 months: This is a mid-intervention assessment, conducted while participants are still receiving the fiber supplementation. • 6 months: This is the post-intervention measurement, taken after completing the full course of treatment. | — |
Countries
Egypt
Contacts
Public ContactShrouk Sayed
kasr alainy faculty of medicine
Outcome results
None listed