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Completed

NCT Number: NCT03452696

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

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.

Completed

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Key information

Conditions

Hypocalcemia; Dietary Calcium Metabolism Disorders Hypocalcemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Palacios

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium supplement

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in bone markers

    Time frame: Basal and 1 month

    Bone Marker Analysis (CTx and P1NP) will be performed

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Collaborators

  • Nexentia S.A.S.

Registry information

Official study 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

Acronym: CALCIMIP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2018
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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