Low Dose Calcium to Prevent Preeclampsia

Phase 4

Completed

• Conditions: Hypertension, Pregnancy-Induced; Pre-Eclampsia; Dietary Calcium Deficiency
• Interventions: Behavioral: Educational sessions; Dietary Supplement: calcium

• Registration Number: NCT02338687
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-11
• Study First Submitted QC: 2015-01-11
• Study First Posted: 2015-01-14
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1040

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Educational sessions	Educational sessions
Education plus supplement	calcium	Educational sessions and 500 mg calcium per day
Education plus supplement	Educational sessions	Educational sessions and 500 mg calcium per day

Primary Outcome Measures

Name	Time	Method
Preeclampsia	at 20-40 weeks of pregnancy	New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Hypertensive disorders of pregnancy	at 20-40 weeks of pregnancy	New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy

Secondary Outcome Measures

Name	Time	Method
Maternal admission to Intensive Care Unit	at 20-40 weeks of pregnancy	admission for any cause
Preterm birth	at 20-36 weeks	Delivery before 37 weeks
Small for gestational age infant	at 20-40 weeks	Birth of an infant whose weight is below the 10th percentile for gestational age
Mean change in dietary calcium intake	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.
Gastrointestinal side effects of calcium	at 20-40 weeks of pregnancy	incidence of flatulence, obstipation or other symptoms any time up to delivery
Low birth weight	at 20-40 weeks	Birth weight less than 2500 g
Hospital admission due to hypertension	at 20-40 weeks of pregnancy	Admission (before labor) due to hypertension
Severe maternal morbidity	at 20-40 weeks of pregnancy	Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome
Maternal mortality	starting at 20 weeks up to hospital discharge	any cause maternal mortality
Admission to Neonatal Intensive Care Unit	from delivery to infant discharge	admission for any cause

Trial Locations

Locations (1)

Universidade Federal do Amazonas; 🇧🇷 Manaus, Amazonas, Brazil