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

NCT03452696 — Phase 3, Completed, 208 participants, Instituto Palacios

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

Registry	NCT03452696, acronym CALCIMIP
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	208 (Actual)
Sponsor	Instituto Palacios (Other); collaborators: Nexentia S.A.S.
Conditions	Hypocalcemia; Dietary
Interventions	Calcium supplement (Dietary supplement)
Dates	start 2018-06-15, primary completion 2019-03-28, completion 2019-04-03, first posted 2018-03-02, last updated 2019-04-08
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Calcium supplement 10/90	Experimental	Dietary Supplement: Calcium supplement	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.
Calcium supplement 5/95	Experimental	Dietary Supplement: Calcium supplement	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
Calcium carbonate supplement	Active comparator	Dietary Supplement: Calcium 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.
Calcium citrate supplement	Active comparator	Dietary Supplement: Calcium 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

Calcium supplement (Dietary supplement): Calcium supplement for low contribution of elemental calcium in the daily diet

+Outcome measures

Primary outcomes

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 outcomes

Changes in bone markers [Basal and 1 month]: Bone Marker Analysis (CTx and P1NP) will be performed

+Eligibility

Sex: Female, ages: 45 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Instituto Palacios	Madrid	Spain

+Investigators

Santiago Palacios, PI, Principal investigator, Instituto Palacios

My Notes

Public

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