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

Instituto Palacios

Status and phase: Completed; Phase 3

Conditions: Hypocalcemia; Dietary

Treatments: Dietary Supplement: Calcium supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03452696

CALCIMIP18

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 4 patient groups

Calcium supplement 10/90

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Calcium supplement

Calcium supplement 5/95

Experimental group

Description:

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

Treatment:

Dietary Supplement: Calcium supplement

Calcium carbonate supplement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Calcium supplement

Calcium citrate supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium supplement