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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypocalcemia; Dietary

Intervention / Treatment
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* Dietary Supplement: Calcium supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium supplement 10/90<br>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<br>* Calcium supplement for low contribution of elemental calcium in the daily diet<br>|
| Experimental: Calcium supplement 5/95<br>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<br>* Calcium supplement for low contribution of elemental calcium in the daily diet<br>|
| Active Comparator: Calcium carbonate supplement<br>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<br>* Calcium supplement for low contribution of elemental calcium in the daily diet<br>|
| Active Comparator: Calcium citrate supplement<br>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<br>* Calcium supplement for low contribution of elemental calcium in the daily diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone markers | Bone Marker Analysis (CTx and P1NP) will be performed | Basal and 1 month |