Orthopedic DisorderNCT05772364
High- Versus Low-calcium Water for Bone Health
A study testing Loading of low-calcium water first, then high-calcium water in people with Orthopedic Disorder and Calcium Metabolism Disorders, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder, Calcium Metabolism Disorders, Bone Resorption
- What is being tested?
- Loading of low-calcium water first, then high-calcium water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2023to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥ 18 and < 30
- Maintenance of diet and physical activity lifestyle throughout the duration of the study
- Acceptance of informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
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.
- Conditions
- Orthopedic Disorder, Calcium Metabolism Disorders, Bone Resorption, Water-Electrolyte Imbalance, Eating, Healthy
- Being tested
- Loading of low-calcium water first, then high-calcium water
- Medical subject headings
- Musculoskeletal Diseases, Calcium Metabolism Disorders, Bone Resorption, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Low-calcium water first, then high-calcium water | Experimental | Participants drink 1.5 L of the designated water Receives: Other: Loading of low-calcium water first, then high-calcium water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood calcium levels
Change of calcium levels (mg/dL) from baseline and after 2.5 hours
Measured: Baseline and 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start2 Mar 2023
- Primary completion11 Feb 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Briguglio, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772364
- Sponsor's protocol ID
- CALIMOS (PI: M Briguglio)
- Other IDs
- L4179
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
- ClinicalTrials.gov ID
- NCT05772364
- Acronym / sponsor ID
- CALIMOS (PI: M Briguglio)
- Conditions
- Orthopedic Disorder, Calcium Metabolism Disorders, Bone Resorption, Water-Electrolyte Imbalance, Eating, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-calcium water first, then high-calcium water | Experimental | Other: Loading of low-calcium water first, then high-calcium waterParticipants drink 1.5 L of the designated water |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 18 and < 30
- Maintenance of diet and physical activity lifestyle throughout the duration of the study
- Acceptance of informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loading of low-calcium water first, then high-calcium waterAll 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 | Other | Low-calcium water first, then high-calcium water |
Primary outcome
Change of blood calcium levels
Time frame: Baseline and 2.5 hours
Change of calcium levels (mg/dL) from baseline and after 2.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Briguglio principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loading of low-calcium water first, then high-calcium water in people with Orthopedic Disorder and Calcium Metabolism Disorders, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood calcium levels (time frame: Baseline and 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.