Back to resultsLow Dose Calcium to Prevent Preeclampsia (AMCAL)
Primary Purpose
Pre-Eclampsia, Hypertension, Pregnancy-Induced, Dietary Calcium Deficiency
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
calcium
Educational sessions
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Eclampsia focused on measuring Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization, Maternal mortality
Eligibility Criteria
Inclusion Criteria:
- Capacity to understand verbal and visual instructions
- Gestational age 16 - 20 weeks
- Live fetus
Exclusion Criteria:
- 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
Sites / Locations
- Universidade Federal do Amazonas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Education
Education plus supplement
Arm Description
Educational sessions
Educational sessions and 500 mg calcium per day
Outcomes
Primary Outcome Measures
Preeclampsia
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Hypertensive disorders of pregnancy
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
Secondary Outcome Measures
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.
Hospital admission due to hypertension
Admission (before labor) due to hypertension
Severe maternal morbidity
Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome
Maternal mortality
any cause maternal mortality
Gastrointestinal side effects of calcium
incidence of flatulence, obstipation or other symptoms any time up to delivery
Maternal admission to Intensive Care Unit
admission for any cause
Admission to Neonatal Intensive Care Unit
admission for any cause
Preterm birth
Delivery before 37 weeks
Low birth weight
Birth weight less than 2500 g
Small for gestational age infant
Birth of an infant whose weight is below the 10th percentile for gestational age
Full Information
NCT ID
NCT02338687
First Posted
January 11, 2015
Last Updated
October 10, 2023
Sponsor
Federal University of São Paulo
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
1. Study Identification
Unique Protocol Identification Number
NCT02338687
Brief Title
Low Dose Calcium to Prevent Preeclampsia
Acronym
AMCAL
Official Title
Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Hypertension, Pregnancy-Induced, Dietary Calcium Deficiency
Keywords
Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization, Maternal mortality
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1040 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Educational sessions
Arm Title
Education plus supplement
Arm Type
Experimental
Arm Description
Educational sessions and 500 mg calcium per day
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium
Intervention Description
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
Intervention Type
Behavioral
Intervention Name(s)
Educational sessions
Other Intervention Name(s)
Dietary counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Preeclampsia
Description
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Time Frame
at 20-40 weeks of pregnancy
Title
Hypertensive disorders of pregnancy
Description
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
Time Frame
at 20-40 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Mean change in dietary calcium intake
Description
At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated.
Time Frame
at 30-36 weeks of pregnancy
Title
Hospital admission due to hypertension
Description
Admission (before labor) due to hypertension
Time Frame
at 20-40 weeks of pregnancy
Title
Severe maternal morbidity
Description
Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome
Time Frame
at 20-40 weeks of pregnancy
Title
Maternal mortality
Description
any cause maternal mortality
Time Frame
starting at 20 weeks up to hospital discharge
Title
Gastrointestinal side effects of calcium
Description
incidence of flatulence, obstipation or other symptoms any time up to delivery
Time Frame
at 20-40 weeks of pregnancy
Title
Maternal admission to Intensive Care Unit
Description
admission for any cause
Time Frame
at 20-40 weeks of pregnancy
Title
Admission to Neonatal Intensive Care Unit
Description
admission for any cause
Time Frame
from delivery to infant discharge
Title
Preterm birth
Description
Delivery before 37 weeks
Time Frame
at 20-36 weeks
Title
Low birth weight
Description
Birth weight less than 2500 g
Time Frame
at 20-40 weeks
Title
Small for gestational age infant
Description
Birth of an infant whose weight is below the 10th percentile for gestational age
Time Frame
at 20-40 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Capacity to understand verbal and visual instructions
Gestational age 16 - 20 weeks
Live fetus
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Regina Torloni, MD, PhD
Organizational Affiliation
Sao Paulo Federal University
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal do Amazonas
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69077000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Low Dose Calcium to Prevent Preeclampsia
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