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High- Versus Low-calcium Water for Bone Health

Primary Purpose

Orthopedic Disorder, Calcium Metabolism Disorders, Bone Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Loading of low-calcium water first, then high-calcium water
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Orthopedic Disorder

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body mass index ≥ 18 and < 30 Maintenance of diet and physical activity lifestyle throughout the duration of the study Acceptance of informed consent Exclusion Criteria: 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)

Sites / Locations

  • IRCCS Istituto Ortopedico GaleazziRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-calcium water first, then high-calcium water

Arm Description

Participants drink 1.5 L of the designated water

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
May 4, 2023
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT05772364
Brief Title
High- Versus Low-calcium Water for Bone Health
Official Title
Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Calcium Metabolism Disorders, Bone Resorption, Water-Electrolyte Imbalance, Eating, Healthy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-calcium water first, then high-calcium water
Arm Type
Experimental
Arm Description
Participants drink 1.5 L of the designated water
Intervention Type
Other
Intervention Name(s)
Loading of low-calcium water first, then high-calcium water
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of blood calcium levels
Description
Change of calcium levels (mg/dL) from baseline and after 2.5 hours
Time Frame
Baseline and 2.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index ≥ 18 and < 30 Maintenance of diet and physical activity lifestyle throughout the duration of the study Acceptance of informed consent Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Cittera
Phone
00390283502224
Email
elena.cittera@grupposandonato.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Briguglio
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Cittera
Phone
00390283502224
Email
elena.cittera@grupposandonato.it
First Name & Middle Initial & Last Name & Degree
Matteo Briguglio

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High- Versus Low-calcium Water for Bone Health

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