Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

NCT05854342 | Completed DMC

• 1 other identifier: CECN/1522
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water

Conditions

Osteoporosis Risk

Keywords

bicarbonate-calcium water

Outcome Measures

Primary Outcomes (4)

• calcium (mg/dL)

  change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests

  0-3-6 month

• 25-OH vitamin D (ng/mL)

  change of physiological parameter concentration related to calcium metabolism

  0-3-6 month

• osteocalcin (ng/mL)

  change of physiological parameter concentration related to calcium metabolism

  0-3-6 month

• Parathyroid hormone (pg/mL)

  change of physiological parameter concentration related to calcium metabolism

  0-3-6 month

Secondary Outcomes (1)

• NMR metabolomic profile and applications of Metabolomics in calcium metabolism

  0-3-6 month

Other Outcomes (4)

• changes cholesterol total (mg/dL)

  0-3-6 month

• changes cholesterol HDL (mg/dL)

  0-3-6 month

• changes cholesterol LDL (mg/dL)

  0-3-6 month

Study Arms (2)

bicarbonate-calcium water

EXPERIMENTAL

participants of this group drink bicarbonate-calcium water

Other: bicarbonate-calcium water

low mineral water

NO INTERVENTION

participants of this group drink low mineral water

Interventions

bicarbonate-calcium water OTHER

water with high content of bicarbonate and calcium, low sodium

bicarbonate-calcium water

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal women aged ≥40 years
• Menopausal women, period of early menopause 1-10 years

You may not qualify if:

• estrogen-replacement hormone therapy
• osteoporosis therapy
• corticosteroid therapy
• insulin therapy.
• calcium supplementation
• kidney diseases of medium-severe level
• liver diseases of medium-severe level
• severe osteoporosis

Sponsors & Collaborators

• University of Salerno: lead
• San Giuseppe Moscati Hospital: collaborator

Study Sites (1)

University of Salerno

Salerno, 84084, Italy

Location

Related Publications (2)

• Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3.

  PMID: 15744450 BACKGROUND

• Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26.

  PMID: 18926940 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Full Professor Luca Rastrelli

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 11, 2023
• Study Start: June 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

IT (1)