---
title: Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate
nct_id: NCT03452696
overall_status: COMPLETED
phase: PHASE3
sponsor: Instituto Palacios
study_type: INTERVENTIONAL
primary_condition: Hypocalcemia; Dietary
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03452696.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03452696"
ct_last_update_post_date: 2019-04-08
last_seen_at: "2026-05-12T06:14:08.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate

**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

**NCT ID:** [NCT03452696](https://clinicaltrials.gov/study/NCT03452696)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 208
- **Lead Sponsor:** Instituto Palacios
- **Collaborators:** Nexentia S.A.S.
- **Conditions:** Hypocalcemia; Dietary
- **Start Date:** 2018-06-15
- **Completion Date:** 2019-04-03
- **CT.gov Last Update:** 2019-04-08

## 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.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 70 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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
- **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.
- **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

## Interventions

- **Calcium supplement** (DIETARY_SUPPLEMENT) — Calcium supplement for low contribution of elemental calcium in the daily diet

## Primary Outcomes

- **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

- **Changes in bone markers** _(time frame: Basal and 1 month)_

## Locations (1)

- Instituto Palacios, Madrid, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.instituto palacios|madrid||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03452696.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03452696*  
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