Trial | NCT03452696  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    208
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 Started
Jun 15
2018
Primary Completion
Mar 28
2019
Study Completion
Apr 03
2019
Last Update
Apr 08
2019

Dietary Supplement Calcium supplement

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

Calcium supplement 10/90 Experimental

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

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

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

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

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
No Results Posted