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

Hypocalcemia; Dietary Clinical Trial

— CALCIMIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452696
• Other study ID #: CALCIMIP18
• Status: Completed
• Phase: Phase 3
• Start date: June 15, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: April 2019
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 3, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia
• Hypocalcemia; Dietary

Intervention

Dietary Supplement:
• Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	Nexentia S.A.S.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in bone markers	Bone Marker Analysis (CTx and P1NP) will be performed	Basal and 1 month