NCT07149337

Brief Summary

Kidney function declines with age and this could affect phosphate balance after an acute phosphate load (increased phosphate intake). In daily life, we regularly experience acute phosphate loads through our diet. The aim of this clinical study is to determine whether the body's response to increased phosphate intake changes with age and whether there are sex differences in this response.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 22, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

Phosphate homeostasis and agingOral phosphate challenge

Outcome Measures

Primary Outcomes (1)

  • Phosphate in plasma

    Phosphate in plasma 4 hours after the oral phosphate load shows age differences

    The primary outcome will be measured 5 hours after the first blood collection on the day of the study and 4 hours after ingesting the oral phosphate load.

Study Arms (1)

Oral phosphate load

EXPERIMENTAL

Participants will eat a standard phosphate dinner. The next morning, after consuming a standard phosphate breakfast, they will ingest a phosphate load (558 mg phosphorus) and provide blood and urine samples for nine hours.

Other: Oral phosphate load

Interventions

Participants ingest an oral phosphate load containing 558 mg of phosphorus once.

Oral phosphate load

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers 18-25 and 63-70 years old
  • ≥ BMI \< 26 kg/m2
  • ≥ phosphate in plasma ≤ 1.45 mM
  • ≥ calcium in plasma ≤ 2.50 mM
  • ≥ PTH in plasma ≤ 65 pg/ml
  • eGFR ≥ 60 ml/min/1-73 m2
  • ≥ Systolic blood pressure ≤ 140 mmHg
  • ≥ Diastolic blood pressure ≤ 85 mmHg
  • No hematuria and no acute urinary tract infection
  • Ability and willingness to participate in the study
  • Voluntary signed inform consent

You may not qualify if:

  • Diabetes mellitus
  • Pregnancy
  • History of kidney stones
  • History of parathyroidectomy
  • History of anorexia nervosa
  • History of bulimia
  • History of solid organ transplantation.
  • Nephrolithiasis
  • Sarcoidosis
  • Chronic pancreatitis
  • Chronic diarrhea
  • Chronic liver disease
  • Complete distal renal acidosis (dRTA)
  • Cystinuria
  • Hypo- or hyperaldosteronism
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Carsten A Wagner, Prof. MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2025

First Posted

September 2, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

September 2, 2025

Record last verified: 2025-08