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

Not Applicable

• Conditions: -O149 Pre-eclampsia, unspecified; Pre-eclampsia, unspecified; O149

• Registration Number: PER-013-02
• Lead Sponsor: INSTITUTO DE INVESTIGACION NUTRICIONAL,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-01-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>2. Monitoring of standardized measurements of blood pressure and routine urine tapping for proteinuria at each CPN visit.<br>3. Assessment of birth weight and gestational age at birth or soon after.<br>Measure:Increasing calcium intake in pregnant nulliparous women with low calcium diets leads to a clinically relevant reduction in the incidence of pre-eclampsia.<br>Timepoints:20 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:not contemplated<br><br>Measure:not contemplated<br><br>Timepoints:not contemplated<br>