Low Dose Calcium to Prevent Preeclampsia

Pre-Eclampsia Clinical Trial

— AMCAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338687
• Other study ID #: 528759
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2023
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Calcium Deficiency
• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Universidade Federal do Amazonas	Manaus	Amazonas

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of São Paulo	FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas), PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde), Universidade Federal do Amazonas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia	New onset of hypertension plus proteinuria after 20 weeks of pregnancy	at 20-40 weeks of pregnancy
Primary	Hypertensive disorders of pregnancy	New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy	at 20-40 weeks of pregnancy
Secondary	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
Secondary	Hospital admission due to hypertension	Admission (before labor) due to hypertension	at 20-40 weeks of pregnancy
Secondary	Severe maternal morbidity	Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome	at 20-40 weeks of pregnancy
Secondary	Maternal mortality	any cause maternal mortality	starting at 20 weeks up to hospital discharge
Secondary	Gastrointestinal side effects of calcium	incidence of flatulence, obstipation or other symptoms any time up to delivery	at 20-40 weeks of pregnancy
Secondary	Maternal admission to Intensive Care Unit	admission for any cause	at 20-40 weeks of pregnancy
Secondary	Admission to Neonatal Intensive Care Unit	admission for any cause	from delivery to infant discharge
Secondary	Preterm birth	Delivery before 37 weeks	at 20-36 weeks
Secondary	Low birth weight	Birth weight less than 2500 g	at 20-40 weeks
Secondary	Small for gestational age infant	Birth of an infant whose weight is below the 10th percentile for gestational age	at 20-40 weeks