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

Instituto Palacios1 site in 1 country208 target enrollmentJune 15, 2018

ConditionsHypocalcemia; Dietary

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypocalcemia; Dietary
Sponsor: Instituto Palacios
Enrollment: 208
Locations: 1
Primary Endpoint: Gastric symptoms
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 15, 2018

End Date

April 3, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Instituto Palacios

Responsible Party

Principal Investigator

Dr. Santiago Palacios

Principal Investigator

Instituto Palacios

Eligibility 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

Outcomes

Primary Outcomes

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