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

Instituto Palacios208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

208

Conditions

Hypocalcemia; Dietary

Interventions

Calcium supplementDIETARY_SUPPLEMENT

Calcium supplement for low contribution of elemental calcium in the daily diet

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Instituto Palacios

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

Changes in bone markers

Bone Marker Analysis (CTx and P1NP) will be performed

Time frame: Basal and 1 month

Data from ClinicalTrials.gov

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