NCT03452696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

February 26, 2018

Last Update Submit

April 5, 2019

Conditions

Hypocalcemia; Dietary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in bone markers

    Basal and 1 month

Study Arms (4)

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.

Dietary Supplement: Calcium supplement

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

Dietary Supplement: Calcium supplement

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.

Dietary Supplement: Calcium supplement

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

Dietary Supplement: Calcium supplement

Interventions

Calcium supplementDIETARY_SUPPLEMENT

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

Calcium carbonate supplementCalcium citrate supplementCalcium supplement 10/90Calcium supplement 5/95

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal woman
  • Low contribution of elemental calcium in the daily diet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Santiago Palacios, PI

    Instituto Palacios

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Women
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

June 15, 2018

Primary Completion

March 28, 2019

Study Completion

April 3, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

ES(1)