Liposomal iron dramatic effect on chronic kidney disease pediatric anemia: a randomized clinical trial Sahar Kamal Hegazy, Mai Salah El-Din Koura, Mohamed Shokry Elharoun Pediatric Research, 2026 Background Anemia affects pediatric quality of life. It can cause hypoxia and loss of concentration. There are a lot of iron supplements used in treating pediatric CKD-induced anemia our study aimed to evaluate the effectiveness of oral liposomal iron in treating pediatric CKD anemia compared tointravenous iron dextran. Methods This randomized, parallel study was conducted on 60 CKD pediatric patients. The patients were categorized into two groups. Group 1 comprises 30 pediatric patients administered oral liposomal iron 30 mg/day for 3 months. Group 2 comprises 30 pediatric patients administered intravenous iron dextran 50 mg three times/ week for 3 months. Results Both groups have no statistically significant difference in Hb, RBCS, MCV, PLTs, RDW-CV, Cr, Hepcidin, Ferritin, Iron, and Transferrin levels after 3 months of treatment. Liposomal iron has higher efficacy than IV dextran after 3 months of treatment since there is a significant difference within the group between before and after treatment period at Hb, RBCS, HCT, MCV, RDW-CV, Hepcidin, Ferritin, Iron, TIBC, and Transferrin levels with no reported side effects during the study period. Conclusion Oral liposomal iron has higher efficacy than IV dextran, which is the traditional CKD anemia treatment in pediatric with no reported side effects. Impact The key message of our article is to determine a safe, effective, easy to use, and less costly treatment of chronic kidney disease anemia in pediatrics. Our study will add to the existing literature a suggestion of an effective and safe treatment for pediatric chronic disorder, the traditional treatment has a lot of serious side effects. The impact of our study is to treat anemia resulted from chronic kidney disease in pediatrics with oral drug that has higher efficacy than the traditional injectable drug, this will lead to higher rate of anemia treatment due to higher rate of children compliance.
Repurposing minocycline as an added-on treatment for ulcerative colitis patients on mesalamine: a randomized clinical pilot study Amira F. Mashaly, Sahar K. Hegazy, Monir M. Bahgat Naunyn Schmiedeberg S Archives of Pharmacology, 2026 One of the most prevalent forms of chronic inflammatory bowel disease is ulcerative colitis (UC). The key characteristics observed in UC patients involve fecal urgency, abdominal discomfort, and bloody diarrhea, all of which significantly lower their quality of life. Preclinical studies investigated the protective effect of minocycline in animal models of colitis. This study aimed to assess minocycline’s potential efficacy and safety in mesalamine-treated UC patients. This randomized, controlled pilot clinical research included 46 individuals with mild to moderate UC who met the inclusion criteria. The mesalamine group ( n = 23) received 1 g of mesalamine three times a day for 6 months. The minocycline group ( n = 23) received minocycline 100 mg twice daily and mesalamine 1 g three times a day. Patients were evaluated by a gastroenterologist using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Truelove and Witts Severity Index, Brief Pain Inventory (BPI), and the non-invasive Partial Mayo Score (PMS). Before and after 6 months of treatment, each patient’s levels of nitric oxide (NO), matrix metalloproteinase-12 (MMP-12), and intracellular adhesion molecule 1 (ICAM-1) were measured. Serum levels of MMP-12, ICAM-1, and NO were statistically lower in the minocycline group than in the mesalamine group. In the minocycline group, the Truelove and Witts Severity Index, PMS, and BPI pain intensity all significantly dropped, whereas SIBDQ was substantially elevated compared to the mesalamine group. Minocycline could serve as a potential adjunctive remedy for enhancing clinical outcomes, improving quality of life, and modulating inflammation in patients with mild to moderate UC. Trial registration : ClinicalTrials.gov ID: NCT06201793. Trial registration date 22–1-2024.
Oral lactoferrin as a treatment of pediatrics’ anemia resulted from chronic kidney diseases: a randomized controlled trial Sahar Kamal Hegazy, Mai Salah El-Din Koura, Mohamed Shokry Elharoun Scientific Reports, 2025 Anemia in pediatrics is often associated with chronic conditions such as chronic kidney disease (CKD). It can worsen the disease prognosis and affect quality of life. Injectable dosage forms are predominantly used in its treatment with various side effects. This randomized and parallel clinical trial aimed to compare the effectiveness of oral lactoferrin with intravenous (IV) iron dextran in managing anemia resulted from CKD in pediatrics. The study involved 60 children diagnosed with CKD-related anemia who were allocated into two separate groups. Group 1 consisted of 30 pediatric patients who received 100 mg of oral lactoferrin daily for a period of 3 months. Group 2 included 30 pediatric patients who were given IV iron dextran at a dosage of 50 mg three times weekly for 3 months. Both treatments are effective in treating CKD-induced anemia in pediatrics; however, oral lactoferrin demonstrated superior efficacy as there was a significant change within that group in levels of Hb, RBCs, MCH, iron, RDW-SD, MCHC, IL-6, and GDF-15 before and after treatment. In contrast, IV iron dextran showed significant changes within its group in iron, GFR, IL-6, GDF-15, and RDW-SD. After 3 months of treatment, no significant differences were observed between the two groups.
L-carnitine as a novel approach for pain and inflammation relief in rheumatoid arthritis Abdallah A. Eldisouky, Sahar K. Hegazy, Salwa Elmorsy Abd Elghany Inflammopharmacology, 2025 Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint inflammation, largely mediated by pro-inflammatory cytokines. Considering the established involvement of the Janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway and transforming growth factor-beta1 (TGF-β1) in RA, this research aimed to assess efficacy and safety of L-carnitine as an adjunct therapy targeting these pathways. Forty-six patients with active RA were randomly divided into two equal groups. Group1 (control group) received disease-modifying antirheumatic drugs (DMARDs), including methotrexate, leflunomide, and hydroxychloroquine. Group2 (L-carnitine group) received, DMARDs plus L-carnitine 500 mg twice daily for 12 weeks. A clinical evaluation was conducted, which included tender joint count (TJC), swollen joint count (SJC), pain intensity quantified via the visual analogue scale (VAS), and morning stiffness duration. Additionally, the Disease Activity Score in 28 joints (DAS28) and functional capability as measured by a modified health assessment questionnaire (MHAQ) were assessed. Laboratory evaluation included C-reactive protein (CRP), STAT3, and TGF-β1 measurement. All evaluations were executed both at baseline and following a 12-week treatment period. After 12 weeks, the L-carnitine group showed significant improvement in morning stiffness, VAS, TJC, CRP, DAS28, and MHAQ compared to baseline. While no significant within-group changes were observed in STAT3, TGF-β1 in the L-carnitine group, STAT3 levels increased significantly in the control group compared to baseline. In conclusion, L-carnitine in combination with DMARDs may enhance clinical outcomes in RA by mitigating systemic inflammation. Nevertheless, its impact on STAT3 and TGF-β1 remains unclear and warrants further research.
Repurposing Atorvastatin, HMGCO-A Reductase Inhibitor, in Patients with Ulcerative Colitis: A Randomized Controlled Study Hayam Ali AlRasheed, Sahar M. El-Haggar, Sahar K. Hegazy, Maha M. Maher, Monir M. Bahgat, et al. Journal of Clinical Medicine, 2025 Background/Objective: Among the inflammatory bowel illnesses, ulcerative colitis (UC) affects 5 million people worldwide. UC manifests as weight loss, rectal bleeding, persistent diarrhea, and abdominal pain. Experimental research focused into the potential benefits of atorvastatin for colitis, although the literature only has a small amount of clinical evidence. To examine atorvastatin’s protective effect in UC patients by assessing its impact on fecal myeloperoxidase, zonulin, and disease activity index (DAI). Methods: Two groups of patients with mild to moderate UC were randomly assigned. Over a six-month period, the control group (placebo group) received a placebo alongside mesalamine (1 g, three times daily [t.i.d.]). The atorvastatin group received atorvastatin (80 mg once daily) in addition to mesalamine (1 g t.i.d.). Disease severity was assessed by a gastroenterologist using the Disease Activity Index (DAI). Serum zonulin and fecal myeloperoxidase levels were measured before and after treatment to assess the biological efficacy of the interventions. Outcomes: Reduction in DAI and biomarker levels. Results: Both groups showed a significant decrease in DAI, zonulin, and fecal myeloperoxidase levels. However, the atorvastatin group (n = 23) demonstrated a significantly greater decrease in zonulin (p = 0.04), fecal myeloperoxidase (p = 0.03), and DAI (p = 0.001) compared to the placebo group (n = 24). In atorvastatin group, a significant correlation was observed between DAI and zonulin (p = 0.007, r = 0.4) and myeloperoxidase (p = 0.02, r = 0.36). Conclusions: The co-administration of atorvastatin may serve as a potential adjunct therapy for patients with UC.
The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study Ammena Y. Binsaleh, Sahar M. El-Haggar, Sahar K. Hegazy, Maha M. Maher, Monir M. Bahgat, et al. Frontiers in Pharmacology, 2025 BackgroundMetformin, hypoglycemic medication, is recognized for its diverse properties and its capacity to influence the inflammatory pathways. Medications with anti-inflammatory and anti-oxidative characteristics have been demonstrated to be able to elicit and sustain remission in ulcerative colitis (UC), chronic inflammatory disorder of the bowel. Studies in both preclinical and clinical settings have looked into the several metabolic pathways via which metformin protects against UC.AimTo assess efficacy of metformin as adjunctive therapy in patients with mild to moderate UC.MethodsThis clinical research was double-blinded, randomized, controlled, and involved 60 patients with mild to moderate UC. The participants were randomly assigned to one of two groups (n = 30). The control group was given 1 g of mesalamine three times a day (t.i.d.) for a period of 6 months (mesalamine group). The metformin group was given 500 mg of metformin twice daily and 1 g of mesalamine t. i.d. For a period of 6 months. Patients with UC were assessed by a gastroenterologist using the disease activity index (DAI) both at the beginning of treatment and 6 months thereafter. To evaluate the drug’s biological efficacy, measurements of fecal calprotectin, serum C-reactive protein (CRP), interleukin 10 (IL-10), and nitric oxide (NO) were taken both before and after treatment.Study outcomesDecrease in DAI and change in the level of measured serum and fecal markers.ResultsThe metformin group displayed a statistical reduction in DAI (p = 0.0001), serum CRP (p = 0.019), NO (p = 0.04), and fecal calprotectin (p = 0.027), as well as a significant increase in IL-10 (p = 0.04) when compared to the mesalamine group. There was a significant direct correlation between DAI and calprotectin (p < 0.0001, r = 0.551), and between DAI and CRP (p < 0.0001, r = 0.794). There was a significant negative correlation between DAI and IL-10 (p = 0.0003, r = 0.371).ConclusionMetformin may be an effective adjunct drug in management of patients with mild to moderate UC by decreasing DAI and other inflammatory markers that were involved in the pathogenesis of UC.Clinical Trial Registrationidentifier NCT05553704.
Tadalafil versus pentoxifylline in the management of diabetic kidney disease: a randomized clinical trial Sahar Kamal Hegazy, Walaa Ahmed Amaar, Wafaa Salah Mohamed Hegab Diabetology and Metabolic Syndrome, 2024 Aims To investigate the efficacy and safety of tadalafil (TAD) versus pentoxifylline (PTX) in the management of diabetic kidney disease (DKD). Some animal studies and clinical trials reported that tadalafil and pentoxifylline have a reducing effect on different blood glucose parameters and lipid profiles which contribute to progress the patients with diabetes mellitus (DM) to DKD. Methods From February 2022 to March 2023, 90 patients with type 2 DM and DKD (micro-albuminuria) were enrolled in this randomized-controlled study. The patients were randomized into three equal groups: control group, TAD group, and PTX group. The three groups received traditional blood glucose lowering therapy + ramipril 10 mg PO. The TAD group also received tadalafil 20 mg PO every other day. The PTX group also received pentoxifylline 400 mg PO twice daily. Results Both TAD and PTX groups produced statistically significant improvement in the primary outcomes by a significant reduction in Urinary albumin/creatinine ratio (UACR) which was pronounced by a reduction percentage of—47.47%, −53.73% respectively. In addition to a significant decrease in Hemoglobin A1C (HbA1c) (mmol/mol), Fasting blood glucose (FBG), 2-h postprandial blood glucose (2-h PPG) (p < 0.001). Only the PTX group showed a significant increase in Cr Cl and a significant decrease in S. Cr (p < 0.001). Only the TAD group showed a significant increase in high-density lipoprotein—cholesterol (HDL-C) (p < 0.001), while the PTX group showed a significant decrease in low-density lipoprotein—cholesterol (LDL-C) (p-value 0.011), and triglyceride (p-value 0.002). Both TAD and PTX groups showed a decrease in tumor necrosis factor-α (TNF-α) which was significant only in the PTX group (p < 0.001). There was a significant increase in malondialdehyde (MDA) (p < 0.001), and an increase in urinary neutrophil gelatinase-associated Lipocalin (uNGAL) (p-value 0.850, 0.014 respectively) which was significant only in the PTX group. Conclusions The use of tadalafil or pentoxifylline may serve as an effective adjuvant therapy for patients with diabetic kidney disease. Trial Registration: ClinicalTrials.gov identifier NCT05487755, July 25, 2022.
