Low Dose Calcium to Prevent Preeclampsia (AMCAL)

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Dietary Calcium Deficiency

Treatments: Behavioral: Educational sessions; Dietary Supplement: calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT02338687

528759

Details and patient eligibility

About

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.

Enrollment: 1,040 patients

Sex: Female

Ages: 10 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,040 participants in 2 patient groups

Education

Active Comparator group

Description:

Educational sessions

Treatment:

Behavioral: Educational sessions

Education plus supplement

Experimental group

Description:

Educational sessions and 500 mg calcium per day

Treatment:

Dietary Supplement: calcium

Behavioral: Educational sessions