Hypocalcemia; DietaryPhase 3CALCIMIPNCT03452696

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

A Phase 3 study testing Calcium supplement in people with Hypocalcemia; Dietary, run by Instituto Palacios at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 45 to 70 years, women only
Conditions the study is for: Hypocalcemia; Dietary
What is being tested?: Calcium supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 1 siteSpain
Study dates: 15 Jun 2018to 3 Apr 2019
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal woman
Low contribution of elemental calcium in the daily diet

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

Instituto Palacios
Madrid, 28009

Other trials in Spain

About this study

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

Conditions: Hypocalcemia; Dietary
Being tested: Calcium supplement
Medical subject headings: Hypocalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03452696
Study group	Role	What they receive
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. Receives: 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 Receives: 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. Receives: 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 Receives: Dietary Supplement: Calcium supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 month

Secondary outcomes (1)

Changes in bone markers
Bone Marker Analysis (CTx and P1NP) will be performed
Measured: Basal and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20183 Apr 2019

First posted2 Mar 2018
Study start15 Jun 2018
Primary completion28 Mar 2019
Study completion3 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypocalcemia; DietaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03452696
Sponsor's protocol ID: CALCIMIP18
Acronym: CALCIMIP
Status last verified: Apr 2019
First submitted: 26 Feb 2018
Last updated: 8 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03452696
Acronym / sponsor ID: CALCIMIP / CALCIMIP18
Conditions: Hypocalcemia; Dietary
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Instituto PalaciosUniversity, hospital or other
Collaborators: Nexentia S.A.S.
Study start: 15 Jun 2018 (actual)
Primary completion: 28 Mar 2019 (actual)
Study completion: 3 Apr 2019 (actual)
First posted: 2 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Calcium supplement 10/90	Experimental	Dietary Supplement: Calcium supplementMicroencapsulated 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	Dietary Supplement: Calcium supplementMicroencapsulated 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	Dietary Supplement: Calcium supplement1,250 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	Dietary Supplement: Calcium supplement1,500 mg orally (315 mg of calcium element). There will be 2 taken orally, to make a total contribution of 945 mg. calcium element

Who may qualify

Ages: 45 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Postmenopausal woman
Low contribution of elemental calcium in the daily diet

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcium supplementCalcium supplement for low contribution of elemental calcium in the daily diet	Dietary supplement	Calcium carbonate supplement, Calcium citrate supplement, Calcium supplement 10/90, Calcium supplement 5/95

Primary outcome

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

1 secondary outcome

Changes in bone markers
Time frame: Basal and 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Santiago Palacios, PI principal investigator

Instituto Palacios

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium supplement in people with Hypocalcemia; Dietary, run by Instituto Palacios at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric symptoms (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03452696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.