Assessing How the Body Responds to Increased Phosphate Intake, and How This Response Depends on Age and Sex.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral phosphate load.
- Who it may be relevant to
- Registry conditions: Aging, Kidney Disease, Mineral Metabolism. Basic parameters: 25 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing Human Phosphate Tolerance and Its Dependency on Age and Sex
Overview
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.
Detailed description
Forty subjects (males and females aged 18-25 or 63-70) will ingest an oral phosphate load, after which their body's response will be assessed by collecting blood and urine samples over a period of ten hours.
Interventions
- Other Oral phosphate load
Participants ingest an oral phosphate load containing 558 mg of phosphorus once.
Primary outcome measures
- Phosphate in plasma [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- Healthy volunteers 18-25 and 63-70 years old
- 18.5 ≥ BMI < 26 kg/m2
- 0.84 ≥ phosphate in plasma ≤ 1.45 mM
- 2.20 ≥ calcium in plasma ≤ 2.50 mM
- 15 ≥ PTH in plasma ≤ 65 pg/ml
- eGFR ≥ 60 ml/min/1-73 m2
- 90 ≥ Systolic blood pressure ≤ 140 mmHg
- 60 ≥ 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
Exclusion criteria
- 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
- Hyper- or hypotension
- Hypernatremia
- Gastrointestinal disorders
- Known hypersensitivity reactions to azoic dyes, acetylsalicylic acid, as well as antirheumatic drugs and painkillers (prostaglandin synthesis inhibitors).
Intake of vitamin D and calcium supplements, phosphate, bisphosphonates, cinacalcet, denusomab, teriparatide, systemic glucocorticoids or mineralcorticoids, antiepileptics, carboanydrase inhibitors or diuretics
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07149337 · 2024-02538