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Completed

NCT Number: NCT02338687

Low Dose Calcium to Prevent Preeclampsia

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.

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Key information

Conditions

Pre-eclampsia Cardiovascular Diseases Death Dietary Calcium Deficiency Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

10 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Federal do Amazonas

Manaus, Amazonas, 69077000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium

Dietary Supplement

one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

Educational sessions

Behavioral

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

Primary outcomes

  1. Preeclampsia

    Time frame: at 20-40 weeks of pregnancy

    New onset of hypertension plus proteinuria after 20 weeks of pregnancy

  2. 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

Secondary outcomes

  1. Mean change in dietary calcium intake

    Time frame: at 30-36 weeks of pregnancy

    At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated.

  2. Hospital admission due to hypertension

    Time frame: at 20-40 weeks of pregnancy

    Admission (before labor) due to hypertension

  3. Severe maternal morbidity

    Time frame: at 20-40 weeks of pregnancy

    Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome

  4. Maternal mortality

    Time frame: starting at 20 weeks up to hospital discharge

    any cause maternal mortality

  5. Gastrointestinal side effects of calcium

    Time frame: at 20-40 weeks of pregnancy

    incidence of flatulence, obstipation or other symptoms any time up to delivery

  6. Maternal admission to Intensive Care Unit

    Time frame: at 20-40 weeks of pregnancy

    admission for any cause

  7. Admission to Neonatal Intensive Care Unit

    Time frame: from delivery to infant discharge

    admission for any cause

  8. Preterm birth

    Time frame: at 20-36 weeks

    Delivery before 37 weeks

  9. Low birth weight

    Time frame: at 20-40 weeks

    Birth weight less than 2500 g

  10. Small for gestational age infant

    Time frame: at 20-40 weeks

    Birth of an infant whose weight is below the 10th percentile for gestational age

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
  • PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)
  • Universidade Federal do Amazonas

Registry information

Official study title

Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study

Acronym: AMCAL

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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