Clincosm LogoSign in Get a demo

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

Sponsor
Instituto Palacios (Other)
Overall Status
Completed
CT.gov ID
NCT03452696
Collaborator
Nexentia S.A.S. (Other)
208
Enrollment
1
Location
4
Arms
9.6
Actual Duration (Months)
21.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Calcium supplement
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Women
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 15, 2018
Actual Primary Completion Date :
Mar 28, 2019
Actual Study Completion Date :
Apr 3, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gastric symptoms [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

Secondary Outcome Measures

  1. Changes in bone markers [Basal and 1 month]

    Bone Marker Analysis (CTx and P1NP) will be performed

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Palacios Madrid Spain 28009

Sponsors and Collaborators

  • Instituto Palacios
  • Nexentia S.A.S.

Investigators

  • Principal Investigator: Santiago Palacios, PI, Instituto Palacios

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Santiago Palacios, Principal Investigator, Instituto Palacios
ClinicalTrials.gov Identifier:
NCT03452696
Other Study ID Numbers:
  • CALCIMIP18
First Posted:
Mar 2, 2018
Last Update Posted:
Apr 8, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypocalcemia
Calcium

Study Results

No Results Posted as of Apr 8, 2019