Brief Summary

The impact of the environment on health is becoming an increasingly important issue in public health policies. Endocrine disruptors (EDs) are substances or mixtures of substances found in many everyday products that interact with the body's endocrine functions. Although their mechanisms of action are not yet fully understood, mechanisms involving endocrine mimicry, antagonism, and epigenetic effects have been described. The effects of the main endocrine disruptors on bone health remain poorly understood. Per- and polyfluoroalkyl substances (PFAS) constitute a large family of synthetic organic compounds used for their non-stick and heat-resistant properties. Perfluorooctanoic acid (PFOA) is a specific PFAS compound used in packaging materials and plastics. One of the known effects of PFAS is their interference with vitamin D through competition at its receptor, thereby reducing bone formation. In addition, PFAS decrease the proliferation of bone cells and reduce extracellular matrix synthesis. From foetal development through adolescence, early life represents a critical period for bone formation. If environmental chemicals can interfere with this process in the general paediatric population, the accumulation of endocrine disruptors may also exert an additional deleterious effect in the context of chronic kidney disease-mineral and bone disorder (CKD-MBD). Indeed, patients with chronic kidney disease (CKD) have a higher incidence of fractures and present mineral, skeletal, and cardiovascular abnormalities whose pathophysiology is extremely complex. The potential impact of endocrine disruptors on the pathophysiology of CKD-MBD in children has never been evaluated, despite the fact that during dialysis sessions, blood repeatedly circulates through a circuit composed mainly of plastics and exposed to elevated temperatures. In adult dialysis populations, PFAS exposure has been investigated, but the results are contradictory. In 2018, Liu et al. found no evidence of PFAS removal by haemodialysis. Conversely, studies by Liu et al. (2018) and Huang et al. (2023) demonstrated a significant reduction in PFAS concentrations in patients following haemodialysis sessions and compared with patients with chronic kidney disease not receiving dialysis. Both research groups suggested that PFAS levels in dialysis patients are significantly influenced by the composition and properties of the dialysis membranes used. However, these studies were conducted exclusively in adults, who, by definition, do not have a growing skeleton, and were restricted to PFAS measurements. This is particularly relevant given that: (1) dialysis techniques are rapidly evolving, with hemodiafiltration increasingly replacing conventional haemodialysis and with different membrane types used in paediatric practice; and (2) children undergoing dialysis often require more frequent treatment sessions than adults. For example, according to the French national survey conducted on January 28, 2026, in preparation for discussions on a new dialysis reimbursement model, 25% of the 93 children receiving chronic haemodialysis underwent treatment more than three times per week. Furthermore, none of these studies assessed the impact of peritoneal dialysis, a modality that is relatively uncommon in adults but widely used in paediatrics, particularly among very young children. These considerations have prompted us to evaluate PFAS serum concentrations in children with: (1) chronic kidney disease, (2) peritoneal dialysis, and (3) haemodialysis. This study is designed as a pilot project that may support the development of a larger-scale investigation depending on the results obtained.

Trial Health

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Trial Health Score

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Enrollment

participants targeted

Target at below P25 for all trials

Timeline

18mo left

Started Oct 2026

Geographic Reach

1 country

1 active site

Status

not yet recruiting

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Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

August 10, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

October 10, 2026

Expected

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2028

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

August 10, 2026

Last Update Submit

August 13, 2026

Conditions

Chronic Kidney Disease (CKD)

Keywords

Endocrine disruptorsPaediatric dialysisChronic kidney disease

Outcome Measures

Primary Outcomes (1)

Comparison of blood PFOA concentrations between groups
Day 0