NCT02338687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,040

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

January 11, 2015

Last Update Submit

October 10, 2023

Conditions

Pre-EclampsiaHypertension, Pregnancy-InducedDietary Calcium Deficiency

Keywords

CalciumDietary supplementsHypertension, Pregnancy-InducedPre-EclampsiaNutritional educationDiet therapyDiet recordsHospitalizationMaternal mortality

Outcome Measures

Primary Outcomes (2)

  • Preeclampsia

    New onset of hypertension plus proteinuria after 20 weeks of pregnancy

    at 20-40 weeks of pregnancy

  • Hypertensive disorders of pregnancy

    New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy

    at 20-40 weeks of pregnancy

Secondary Outcomes (10)

  • Mean change in dietary calcium intake

    at 30-36 weeks of pregnancy

  • Hospital admission due to hypertension

    at 20-40 weeks of pregnancy

  • Severe maternal morbidity

    at 20-40 weeks of pregnancy

  • Maternal mortality

    starting at 20 weeks up to hospital discharge

  • Gastrointestinal side effects of calcium

    at 20-40 weeks of pregnancy

  • +5 more secondary outcomes

Study Arms (2)

Education

ACTIVE COMPARATOR

Educational sessions

Behavioral: Educational sessions

Education plus supplement

EXPERIMENTAL

Educational sessions and 500 mg calcium per day

Dietary Supplement: calciumBehavioral: Educational sessions

Interventions

calciumDIETARY_SUPPLEMENT

one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

Education plus supplement
Educational sessionsBEHAVIORAL

Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally

Also known as: Dietary counseling
EducationEducation plus supplement

Eligibility Criteria

Age10 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Capacity to understand verbal and visual instructions
  • Gestational age 16 - 20 weeks
  • Live fetus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Amazonas

Manaus, Amazonas, 69077000, Brazil

Location

MeSH Terms

Conditions

Pre-EclampsiaHypertension, Pregnancy-InducedMaternal Death

Interventions

CalciumNutrition Assessment

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesParental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Maria Regina Torloni, MD, PhD

    Sao Paulo Federal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cluster randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 14, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

BR(1)