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

April 5, 2019 updated by: Dr. Santiago Palacios, Instituto Palacios

Clinical Trial to Evaluate the Gastric Tolerability and Efficacy of the Food Supplement of Microencapsulated Calcium Carbonate vs Conventional Calcium Carbonate and Calcium Citrate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Instituto Palacios

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Dietary supplement: Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
EXPERIMENTAL: 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
Dietary supplement: Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
ACTIVE_COMPARATOR: 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.
Dietary supplement: Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
ACTIVE_COMPARATOR: 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
Dietary supplement: Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric symptoms
Time Frame: 1 month
Using the Gastrointestinal Symptom Rating Scale (GRS). The scale measures constipation, diarrhea, windiness, swelling, nausea, reflux, pain and burning. The patient will have to choose the most appropriate response among those proposed. "Not at all" is the better outcome and "very strong discomfort" is the worst outcome
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in bone markers
Time Frame: Basal and 1 month
Bone Marker Analysis (CTx and P1NP) will be performed
Basal and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Palacios

Collaborators

Nexentia S.A.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2018

Primary Completion (ACTUAL)

March 28, 2019

Study Completion (ACTUAL)

April 3, 2019

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (ACTUAL)

March 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALCIMIP18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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