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Lactoferrin Supplementation in Diabetic Nephropathy

ConditionDiabetic Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactoferrin

    Dietary supplement

    Lactoferrin 250mg/day

  • Antidiabetic

    Drug

    Antidiabetic (insulin+/oral hypoglycemics)

  • Placebo

    Other intervention

    Placebo pills

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Lactoferrin armExperimental treatment 2 interventions
Group B: Placebo armPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Urinary albumin/creatinine ratio

Time frame
Baseline and after 12 weeks

Secondary outcomes

1

Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen).

Time frame
Baseline and after 12 weeks
2

Glycemic indices (fasting blood glucose and hemoglobin A1c).

Time frame
Baseline and after 12 weeks
3

Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides).

Time frame
Baseline and after 12 weeks
4

Body mass index

Weight and height will be combined to report BMI in kg/m\^2

Time frame
Baseline and after 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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