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SUPPLEMENTATION WITH CALCIUM FOR THE PREVENTION OF PRE-ECLAMPSIA IN WOMEN WITH LOW CALCIUM INTAKE

SUPPLEMENTATION WITH CALCIUM FOR THE PREVENTION OF PRE-ECLAMPSIA IN WOMEN WITH LOW CALCIUM INTAKE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-013-02
Enrollment
Unknown
Registered
2002-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

calcium supplement Type of group
They will take three chewable tablets of 500 mg of elemental calcium that should be taken daily. Women will be instructed to chew the tablets during meals, but with a difference of at least three hours from the intake of any iron supplement. Group name:placebo Type of group
they will receive three tablets per day, with the same characteristics, color and flavor as the intervention tablet prepared and packaged by the same pharmaceutical manufacturer. They will take until the birth or until the beginning of any treatment with magnesium sulfate, or until a suspicion of urolithiasis.

Sponsors

INSTITUTO DE INVESTIGACION NUTRICIONAL,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women who attend prenatal care in the participating centers will be eligible if they meet the following criteria: 1. Gestational age <20 weeks 2. Nulliparous 3. Disposition and capacity to give consent (for minors, informed consent will be obtained following the age limits specified by country).

Exclusion criteria

Exclusion criteria: • History of urolithiasis or symptoms suggestive of urolithiasis or any kidney disease, such as hematuria, pain in the flanks, etc. • Parathyroid disease. • Systolic blood pressure greater than or equal to 140 mmHg and / or diastolic greater than or equal to 90 mmHg, • Taking diuretics or any treatment with digoxin. • Plan to give birth at a health service outside the area or at home. • Taking phenytoin or tetracycline.

Design outcomes

Primary

MeasureTime frame
Outcome name:1. Concurrence to the CPN clinics, beginning before week 20 of pregnancy (up to 19 weeks and 6 days). The frequency and content of the visits will follow the standard practice of the clinic but at least one clinical visit will be carried out every four weeks to all the women enrolled. 2. Monitoring of standardized measurements of blood pressure and routine urine tapping for proteinuria at each CPN visit. 3. Assessment of birth weight and gestational age at birth or soon after. Measure:Increasing calcium intake in pregnant nulliparous women with low calcium diets leads to a clinically relevant reduction in the incidence of pre-eclampsia. Timepoints:20 weeks

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Argentina, Egypt, India, Peru, South Africa, Vietnam

Outcome results

None listed

Source: REPEC (via WHO ICTRP)