Lactoferrin Supplementation in Diabetic Nephropathy

NCT07764991 — Phase 2, Recruiting, 60 participants, Ain Shams University

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The Effect of Lactoferrin on the Clinical Outcome of Patients With Diabetic Nephropathy

Registry	NCT07764991
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Ain Shams University (Other)
Conditions	Diabetic Nephropathy
Interventions	Lactoferrin, Antidiabetic, Placebo (Dietary supplement, drug, other)
Dates	start 2025-08-01, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-08-14, last updated 2026-08-14
Locations	1 site in Egypt

-Summary

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 ( ↓ TNF-α, ↓ IL-6, ↓ IFN-γ, ↓ IL-1β, ↑ 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 models with kidney injury have proven the nephroprotective effect of LF through decreasing the levels of urinary albumin to creatinine ratio, serum creatinine, serum urea, and blood urea nitrogen (BUN) and also through reducing the expression of kidney damage markers; osteopontin, renin and IL-6. Furthermore, LF improved glycemic control and lipid markers through significant improvement of HbA1c, FBG, insulin resistance, body mass index and lipid markers.

Hence, this study aims to evaluate the effect of LF on the clinical outcomes of type 2 diabetic patients with DN.

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+Arms and interventions

Arm	Type	Interventions	Description
Lactoferrin arm	Experimental	Dietary Supplement: Lactoferrin; Drug: Antidiabetic	30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks
Placebo arm	Placebo comparator	Drug: Antidiabetic; Other: Placebo	30 patients receiving standard therapy + placebo for 12 weeks.

Lactoferrin (Dietary supplement): Lactoferrin 250mg/day
Antidiabetic (Drug): Antidiabetic (insulin+/oral hypoglycemics)
Placebo (Other): Placebo pills

+Outcome measures

Primary outcomes

Urinary albumin/creatinine ratio [Baseline and after 12 weeks]

Secondary outcomes

Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen). [Baseline and after 12 weeks]
Glycemic indices (fasting blood glucose and hemoglobin A1c). [Baseline and after 12 weeks]
Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides). [Baseline and after 12 weeks]
Body mass index [Baseline and after 12 weeks]: Weight and height will be combined to report BMI in kg/m\^2
Osteopontin as a biomarker of oxidative stress [Baseline and after 12 weeks]
Quality of life using the Kidney Disease Quality of Life Instrument (KDQOL -36™ Survey) [Baseline and after 12 weeks]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Age ≥ 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

+Locations (1)

Facility	City	Country	Status
Ain Shams University Hospitals	Cairo	Egypt	Recruiting