Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate

NCT ID: NCT03452696

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypocalcemia; Dietary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Women

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Calcium supplement 10/90

Microencapsulated calcium, 1389 mg orally (10% protein and 90% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 doses of 1389 mg each orally, to make a total contribution of 1,000 mg. of calcium element.

Group Type EXPERIMENTAL

Calcium supplement

Intervention Type DIETARY_SUPPLEMENT

Calcium supplement for low contribution of elemental calcium in the daily diet

Calcium supplement 5/95

Microencapsulated calcium1316 mg orally (5% protein and 95% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 shots of 1,316 mg each orally, to make a total contribution of 1,000 mg. calcium element

Group Type EXPERIMENTAL

Calcium supplement

Intervention Type DIETARY_SUPPLEMENT

Calcium supplement for low contribution of elemental calcium in the daily diet

Calcium carbonate supplement

1,250 mg orally (500 mg of calcium element). There will be 2 doses of 1,250 mg. each orally, to make a total contribution of 1,000 mg. of calcium element.

Group Type ACTIVE_COMPARATOR

Calcium supplement

Intervention Type DIETARY_SUPPLEMENT

Calcium supplement for low contribution of elemental calcium in the daily diet

Calcium citrate supplement

1,500 mg orally (315 mg of calcium element). There will be 2 taken orally, to make a total contribution of 945 mg. calcium element

Group Type ACTIVE_COMPARATOR

Calcium supplement

Intervention Type DIETARY_SUPPLEMENT

Calcium supplement for low contribution of elemental calcium in the daily diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcium supplement

Calcium supplement for low contribution of elemental calcium in the daily diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal woman
* Low contribution of elemental calcium in the daily diet

Exclusion Criteria

* Hypersensitivity to the active substances or to any of the excipients
* Renal insufficiency
* History of kidney or urinary stones
* Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones
* Use of any other drug or experimental device during the 30 days prior to the selection
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nexentia S.A.S.

UNKNOWN

Sponsor Role collaborator

Instituto Palacios

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Santiago Palacios

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Santiago Palacios, PI

Role: PRINCIPAL_INVESTIGATOR

Instituto Palacios

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Palacios

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CALCIMIP18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

25-Hydroxyvitamin D Pharmacokinetic Study
NCT03401541 COMPLETED EARLY_PHASE1