NCT05772364

Brief Summary

The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 2, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 6, 2023

Last Update Submit

April 27, 2026

Conditions

Calcium Metabolism DisordersOrthopedic DisorderBone ResorptionWater-Electrolyte ImbalanceEating, Healthy

Outcome Measures

Primary Outcomes (1)

  • Change of blood calcium levels

    Change of calcium levels (mg/dL) from baseline and after 2.5 hours

    Baseline and 2.5 hours

Study Arms (1)

Low-calcium water first, then high-calcium water

EXPERIMENTAL

Participants drink 1.5 L of the designated water

Other: Loading of low-calcium water first, then high-calcium water

Interventions

Loading of low-calcium water first, then high-calcium waterOTHER

All cohort subjects are asked to consume water with less than 5 mg/L of calcium first, then are asked to consume water with at least 400 mg/L of calcium

Low-calcium water first, then high-calcium water

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥ 18 and \< 30
  • Maintenance of diet and physical activity lifestyle throughout the duration of the study
  • Acceptance of informed consent

You may not qualify if:

  • Consumption of water with calcium \> 150 mg/L
  • Pregnancy (as established by self-declaration), breastfeeding, menopause
  • Inability to follow the study protocol
  • Cardiac, vascular, renal, and oncological disease
  • Neuropsychiatric disease, developmental disorders
  • Disease or past surgery affecting the gastrointestinal tract
  • Drugs that interfere with bone (e.g. corticosteroids) or with fluid balance (e.g. diuretics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Milan, Italy

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesCalcium Metabolism DisordersBone ResorptionWater-Electrolyte Imbalance

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesBone Diseases

Study Officials

  • Matteo Briguglio

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

March 2, 2023

Primary Completion

February 11, 2026

Study Completion

April 23, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

IT(1)