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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02238704 |
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Date of registration:
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05/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cornell University-Micronutrient Initiative Calcium Supplementation Study
MICA |
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Scientific title:
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A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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1032 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02238704 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Katherine Dickin, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cornell University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Attendance at ANC clinic in a primary care facility in Kakamega north
Exclusion Criteria:
- Gestational age < 16 weeks,
- Gestational age > 30 weeks,
- Dietary or medicinal consumption of adequate calcium (according to the screening
survey),
- Intention to leave study community before 8weeks from date of interview
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preeclampsia
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Intervention(s)
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Dietary Supplement: Regimen B calcium and iron/folic acid
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Dietary Supplement: Regimen A calcium and iron/folic acid
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Primary Outcome(s)
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Amount of calcium supplement ingested
[Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred]
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Secondary Outcome(s)
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Satisfaction
[Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred]
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Adherence to related recommendations
[Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred]
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Self-efficacy
[Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred]
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Motivation
[Time Frame: 8 weeks after ANC consultation, during which recruitment into the study occurred]
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Secondary ID(s)
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P414/01/2013
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IRB #: 1205003071
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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