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

Phase 3

Completed

• Conditions: Hypocalcemia; Dietary
• Interventions: Dietary Supplement: Calcium supplement

• Registration Number: NCT03452696
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Study Start: 2018-06-15
• Primary Completion: 2019-03-28
• Status Verified: 2019-04
• Study Completion: 2019-04-03
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 208

Inclusion Criteria

• Postmenopausal woman
• Low contribution of elemental calcium in the daily diet

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium supplement 5/95	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	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 supplement 10/90	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 citrate 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in bone markers	Basal and 1 month	Bone Marker Analysis (CTx and P1NP) will be performed

Trial Locations

Locations (1)

Instituto Palacios; 🇪🇸 Madrid, Spain