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Lactoferrin Supplementation in Diabetic Nephropathy

RecruitingPhase 2Ages 18 Years - 75 YearsAllAin Shams University
NCT07764991 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Multiple pathways and mediators, including oxidative stress, inflammation, and the over-activity of the renin-angiotensin-aldosterone system are involved in the development of albuminuria and progression of diabetic nephropathy (DN), of which oxidative stress is the most prominent. Previous research has shown that lactoferrin (LF) has multi-pharmacological properties, including antioxidant, anti-inflammatory, antiviral, anticancer, antibacterial, antifibrotic and immunogenic properties . Lactoferrin was reported to be a useful nutritional supplement to support immunity and antioxidant status and suppress systemic inflammatory and oxidative stress biomarkers ( โ†“ TNF-ฮฑ, โ†“ IL-6, โ†“ IFN-ฮณ, โ†“ IL-1ฮฒ, โ†‘ IL-10) in previous studies. Lactoferrin, in vitro, has been reported to reduce oxidative stress, inflammation, apoptosis and fibrosis in acute and chronic kidney disease. Moreover, different rat

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min/1.73m2) or stage 4 (eGFR 15-29 ml/min/1.73m2) * Urinary albumin/Creatinine ratio (UACR): moderately and severely increased albuminuria (\> 30 mg/g) * Stable standard therapy for at least three months prior to inclusion in the study. * Life expectancy \>12 months. Exclusion Criteria: * Participation in other interventional trials * Current or previous treatment with LF supplements at least three months before inclusion. * Kidney donor or recipient * Pregnancy or breastfeeding * Active malignancy * Poor adherence potential (e.g. cognitive impairment, psychiatric instability) * Known intolerance or allergy to lactoferrin
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What it tests

  • Lactoferrin
  • Antidiabetic
  • Placebo
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Where

1 site
Ain Shams University Hospitals
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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