NCT02338687
Completed
Phase 4
Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
Federal University of São Paulo1 site in 1 country1,040 target enrollmentOctober 2014
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- Federal University of São Paulo
- Enrollment
- 1040
- Locations
- 1
- Primary Endpoint
- Preeclampsia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Maria Regina Torloni
MD, PhD
Federal University of São Paulo
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
Outcomes
Primary Outcomes
Preeclampsia
Time Frame: at 20-40 weeks of pregnancy
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
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
- Maternal admission to Intensive Care Unit(at 20-40 weeks of pregnancy)
- Preterm birth(at 20-36 weeks)
- Small for gestational age infant(at 20-40 weeks)
- Severe maternal morbidity(at 20-40 weeks of pregnancy)
- Mean change in dietary calcium intake(at 30-36 weeks of pregnancy)
- Gastrointestinal side effects of calcium(at 20-40 weeks of pregnancy)
- Low birth weight(at 20-40 weeks)
- Hospital admission due to hypertension(at 20-40 weeks of pregnancy)
- Maternal mortality(starting at 20 weeks up to hospital discharge)
- Admission to Neonatal Intensive Care Unit(from delivery to infant discharge)
Study Sites (1)
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