Pre-EclampsiaPhase 4AMCALNCT02338687
Low Dose Calcium to Prevent Preeclampsia
A Phase 4 study testing calcium and Educational sessions in people with Pre-Eclampsia and Hypertension, Pregnancy-Induced, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during… Read more about this study
- Who is it for?
- Ages 10 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Dietary Calcium Deficiency
- What is being tested?
- calcium and Educational sessions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Oct 2018
- Phase
- Phase 4
- 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 10 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Capacity to understand verbal and visual instructions
- Gestational age 16 - 20 weeks
- Live fetus
Who cannot join
- Hyperparathyroidism or other contra-indication to calcium supplementation
- Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis)
- Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones)
- Women already taking calcium supplements or daily antacids at recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.
- Being tested
- calcium, Educational sessions
- Keywords
- Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization, Maternal mortality
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumDietary supplement
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
Educational sessionsBehavioural
Also called Dietary counseling
Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | Educational sessions Receives: Behavioral: Educational sessions |
| Education plus supplement | Experimental | Educational sessions and 500 mg calcium per day Receives: Dietary Supplement: calcium; Behavioral: Educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Measured: at 20-40 weeks of pregnancy
Hypertensive disorders of pregnancy
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
Measured: at 20-40 weeks of pregnancy
Secondary outcomes (10)
Mean change in dietary calcium intake
At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated.
Measured: at 30-36 weeks of pregnancy
Hospital admission due to hypertension
Admission (before labor) due to hypertension
Measured: at 20-40 weeks of pregnancy
Severe maternal morbidity
Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome
Measured: at 20-40 weeks of pregnancy
Maternal mortality
any cause maternal mortality
Measured: starting at 20 weeks up to hospital discharge
Gastrointestinal side effects of calcium
incidence of flatulence, obstipation or other symptoms any time up to delivery
Measured: at 20-40 weeks of pregnancy
Maternal admission to Intensive Care Unit
admission for any cause
Measured: at 20-40 weeks of pregnancy
Admission to Neonatal Intensive Care Unit
admission for any cause
Measured: from delivery to infant discharge
Preterm birth
Delivery before 37 weeks
Measured: at 20-36 weeks
Low birth weight
Birth weight less than 2500 g
Measured: at 20-40 weeks
Small for gestational age infant
Birth of an infant whose weight is below the 10th percentile for gestational age
Measured: at 20-40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized
- Masking
- None (open label)
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde), FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas), Universidade Federal do Amazonas
- Responsible party
- Principal investigator, Maria Regina Torloni, Federal University of São Paulo
- Investigators
- Maria Regina Torloni, MD, PhD, Study chair, Sao Paulo Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338687
- Sponsor's protocol ID
- 528759
- Acronym
- AMCAL
- Status last verified
- Oct 2023
- First submitted
- 11 Jan 2015
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
- ClinicalTrials.gov ID
- NCT02338687
- Acronym / sponsor ID
- AMCAL / 528759
- Keywords
- Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde), FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas), Universidade Federal do Amazonas
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 14 Jan 2015 (estimated)
- 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.
The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: Educational sessionsEducational sessions |
| Education plus supplement | Experimental | Dietary Supplement: calcium, Behavioral: Educational sessionsEducational sessions and 500 mg calcium per day |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Capacity to understand verbal and visual instructions
- Gestational age 16 - 20 weeks
- Live fetus
Key exclusion criteria (4 listed)
- Hyperparathyroidism or other contra-indication to calcium supplementation
- Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis)
- Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones)
- Women already taking calcium supplements or daily antacids at recruitment
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 |
|---|---|---|
| calciumone chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate) | Dietary supplement | Education plus supplement |
| Educational sessionsAlso: Dietary counselingWomen will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally | Behavioural | Education, Education plus supplement |
Primary outcome
Preeclampsia
Time frame: at 20-40 weeks of pregnancy
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Hypertensive disorders of pregnancy
Time frame: at 20-40 weeks of pregnancy
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
10 secondary outcomes
Mean change in dietary calcium intake
Time frame: at 30-36 weeks of pregnancy
Hospital admission due to hypertension
Time frame: at 20-40 weeks of pregnancy
Severe maternal morbidity
Time frame: at 20-40 weeks of pregnancy
Maternal mortality
Time frame: starting at 20 weeks up to hospital discharge
Gastrointestinal side effects of calcium
Time frame: at 20-40 weeks of pregnancy
Maternal admission to Intensive Care Unit
Time frame: at 20-40 weeks of pregnancy
Admission to Neonatal Intensive Care Unit
Time frame: from delivery to infant discharge
Preterm birth
Time frame: at 20-36 weeks
Low birth weight
Time frame: at 20-40 weeks
Small for gestational age infant
Time frame: at 20-40 weeks
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 12 Oct 2023.
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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.
Maria Regina Torloni, MD, PhD study chair
Sao Paulo Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcium and Educational sessions in people with Pre-Eclampsia and Hypertension, Pregnancy-Induced, run by Federal University of São Paulo at 1 site in Brazil.
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 3 inclusion and 4 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 12 Oct 2023. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Preeclampsia (time frame: at 20-40 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.