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

Primary Purpose

Hypocalcemia; Dietary

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Calcium supplement
Sponsored by
Instituto Palacios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypocalcemia; Dietary

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Palacios

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Calcium supplement 10/90

Calcium supplement 5/95

Calcium carbonate supplement

Calcium citrate supplement

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

Gastric symptoms
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

Secondary Outcome Measures

Changes in bone markers
Bone Marker Analysis (CTx and P1NP) will be performed

Full Information

First Posted
February 26, 2018
Last Updated
April 5, 2019
Sponsor
Instituto Palacios
Collaborators
Nexentia S.A.S.
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1. Study Identification

Unique Protocol Identification Number
NCT03452696
Brief Title
Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate
Acronym
CALCIMIP
Official Title
Clinical Trial to Evaluate the Gastric Tolerability and Efficacy of the Food Supplement of Microencapsulated Calcium Carbonate vs Conventional Calcium Carbonate and Calcium Citrate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Palacios
Collaborators
Nexentia S.A.S.

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia; Dietary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Women
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium supplement 10/90
Arm Type
Experimental
Arm Description
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.
Arm Title
Calcium supplement 5/95
Arm Type
Experimental
Arm Description
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
Arm Title
Calcium carbonate supplement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Calcium citrate supplement
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium supplement
Intervention Description
Calcium supplement for low contribution of elemental calcium in the daily diet
Primary Outcome Measure Information:
Title
Gastric symptoms
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in bone markers
Description
Bone Marker Analysis (CTx and P1NP) will be performed
Time Frame
Basal and 1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Palacios, PI
Organizational Affiliation
Instituto Palacios
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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