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

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ClinicalTrials.gov Identifier: NCT03452696
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Nexentia S.A.S.
Information provided by (Responsible Party):
Dr. Santiago Palacios, Instituto Palacios

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
Hypocalcemia; Dietary Dietary Supplement: Calcium supplement Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 15, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in bone markers [ Time Frame: Basal and 1 month ]
    Bone Marker Analysis (CTx and P1NP) will be performed



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452696


Contacts
Contact: Santiago Palacios, MD +34 91 578 05 17 investigacion@institutopalacios.com
Contact: Eva Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com

Locations
Spain
Instituto Palacios
Madrid, Spain, 28009
Sponsors and Collaborators
Instituto Palacios
Nexentia S.A.S.
Investigators
Principal Investigator: Santiago Palacios, PI Instituto Palacios

Responsible Party: Dr. Santiago Palacios, Principal Investigator, Instituto Palacios
ClinicalTrials.gov Identifier: NCT03452696     History of Changes
Other Study ID Numbers: CALCIMIP18
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Calcium, Dietary
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents