Low Dose Calcium to Prevent Preeclampsia (AMCAL)

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Dietary Calcium Deficiency
• Intervention / Treatment: Behavioral: Educational sessions; Dietary supplement: calcium

• Study Type: Interventional
• Enrollment (Actual): 1040
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Celsa da Silva Moura Souza, MsC, Professor; Phone Number: 55 92 9116 4371; Email: celsa22@hotmail.com
• Study Contact Backup: Name: Erika Barbosa Camargo, PhD; Phone Number: 55 11 55752970; Email: erika.barbosacamargo@gmail.com

Study Locations

• Brazil
  • Amazonas
    • Manaus, Amazonas, Brazil, 69077000
      • Universidade Federal do Amazonas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education; Educational sessions	Behavioral: Educational sessions; 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; Other Names: Dietary counseling
Experimental: Education plus supplement; Educational sessions and 500 mg calcium per day	Behavioral: Educational sessions; 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; Other Names: Dietary counseling; Dietary supplement: calcium; one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preeclampsia	New onset of hypertension plus proteinuria after 20 weeks of pregnancy	at 20-40 weeks of pregnancy
Hypertensive disorders of pregnancy	New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy	at 20-40 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 30-36 weeks of pregnancy
Hospital admission due to hypertension	Admission (before labor) due to hypertension	at 20-40 weeks of pregnancy
Severe maternal morbidity	Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome	at 20-40 weeks of pregnancy
Maternal mortality	any cause maternal mortality	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	at 20-40 weeks of pregnancy
Maternal admission to Intensive Care Unit	admission for any cause	at 20-40 weeks of pregnancy
Admission to Neonatal Intensive Care Unit	admission for any cause	from delivery to infant discharge
Preterm birth	Delivery before 37 weeks	at 20-36 weeks
Low birth weight	Birth weight less than 2500 g	at 20-40 weeks
Small for gestational age infant	Birth of an infant whose weight is below the 10th percentile for gestational age	at 20-40 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Universidade Federal do Amazonas; PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde); FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
• Investigators: Study Chair: Maria Regina Torloni, MD, PhD, Sao Paulo Federal University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: January 11, 2015
• First Submitted That Met QC Criteria: January 11, 2015
• First Posted (Estimated): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pre-Eclampsia; Calcium; Hospitalization; Dietary supplements; Diet therapy; Maternal mortality; Hypertension, Pregnancy-Induced; Nutritional education; Diet records
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 528759