Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1040 participants
INTERVENTIONAL
2014-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Education
Educational sessions
Educational sessions
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
Education plus supplement
Educational sessions and 500 mg calcium per day
calcium
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
Educational sessions
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
Interventions
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calcium
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
Educational sessions
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age 16 - 20 weeks
* Live fetus
Exclusion Criteria
* 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
10 Years
55 Years
FEMALE
Yes
Sponsors
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PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)
UNKNOWN
FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
UNKNOWN
Universidade Federal do Amazonas
OTHER
Federal University of São Paulo
OTHER
Responsible Party
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Maria Regina Torloni
MD, PhD
Principal Investigators
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Maria Regina Torloni, MD, PhD
Role: STUDY_CHAIR
Sao Paulo Federal University
Locations
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Universidade Federal do Amazonas
Manaus, Amazonas, Brazil
Countries
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Other Identifiers
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528759
Identifier Type: -
Identifier Source: org_study_id
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