Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-05 @ 11:02 AM
Study NCT ID:
NCT02238704
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cornell University-Micronutrient Initiative Calcium Supplementation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1032}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of calcium supplement ingested', 'timeFrame': '8 weeks after ANC consultation, during which recruitment into the study occurred', 'description': 'This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation.\n\n\\[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)\\] X 100'}], 'secondaryOutcomes': [{'measure': 'Adherence to related recommendations', 'timeFrame': '8 weeks after ANC consultation, during which recruitment into the study occurred', 'description': 'Adherence to other features of the WHO recommendation (taking supplements with food).'}, {'measure': 'Motivation', 'timeFrame': '8 weeks after ANC consultation, during which recruitment into the study occurred', 'description': 'Motivation scores extracted from the survey instrument administered at follow up.'}, {'measure': 'Self-efficacy', 'timeFrame': '8 weeks after ANC consultation, during which recruitment into the study occurred', 'description': 'Self-efficacy scores extracted from the survey instrument administered at follow up.'}, {'measure': 'Satisfaction', 'timeFrame': '8 weeks after ANC consultation, during which recruitment into the study occurred', 'description': 'Satisfaction scores extracted from the survey instrument administered at follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adherence', 'Calcium supplementation', 'Prevention of preeclampsia', 'Adherence to calcium supplementation'], 'conditions': ['Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '30402593', 'type': 'DERIVED', 'citation': 'Martin SL, Wawire V, Ombunda H, Li T, Sklar K, Tzehaie H, Wong A, Pelto GH, Omotayo MO, Chapleau GM, Stoltzfus RJ, Dickin KL. Integrating Calcium Supplementation into Facility-Based Antenatal Care Services in Western Kenya: A Qualitative Process Evaluation to Identify Implementation Barriers and Facilitators. Curr Dev Nutr. 2018 Aug 23;2(11):nzy068. doi: 10.1093/cdn/nzy068. eCollection 2018 Nov.'}, {'pmid': '28878035', 'type': 'DERIVED', 'citation': "Omotayo MO, Dickin KL, Pelletier DL, Mwanga EO, Kung'u JK, Stoltzfus RJ. A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya. J Nutr. 2017 Oct;147(10):1986-1991. doi: 10.3945/jn.117.251926. Epub 2017 Sep 6."}, {'pmid': '28250195', 'type': 'DERIVED', 'citation': 'Martin SL, Omotayo MO, Pelto GH, Chapleau GM, Stoltzfus RJ, Dickin KL. Adherence-Specific Social Support Enhances Adherence to Calcium Supplementation Regimens among Pregnant Women. J Nutr. 2017 Apr;147(4):688-696. doi: 10.3945/jn.116.242503. Epub 2017 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.', 'detailedDescription': 'This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attendance at ANC clinic in a primary care facility in Kakamega north\n\nExclusion Criteria:\n\n* Gestational age \\< 16 weeks,\n* Gestational age \\> 30 weeks,\n* Dietary or medicinal consumption of adequate calcium (according to the screening survey),\n* Intention to leave study community before 8weeks from date of interview'}, 'identificationModule': {'nctId': 'NCT02238704', 'acronym': 'MICA', 'briefTitle': 'Cornell University-Micronutrient Initiative Calcium Supplementation Study', 'organization': {'class': 'OTHER', 'fullName': 'Cornell University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IRB #: 1205003071'}, 'secondaryIdInfos': [{'id': 'P414/01/2013', 'type': 'OTHER', 'domain': 'Kenyatta National Hospital Ethics Review Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A', 'description': '500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 2 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day', 'interventionNames': ['Dietary Supplement: Regimen A calcium and iron/folic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regimen B', 'description': '500mg elemental calcium (as CaCO3) + 200 microgram Vit D per administration, administered 3 times a day, at least 2hours apart with one administration of 60mg elemental iron (as FeSO4) at any time of the day', 'interventionNames': ['Dietary Supplement: Regimen B calcium and iron/folic acid']}], 'interventions': [{'name': 'Regimen A calcium and iron/folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women', 'armGroupLabels': ['Regimen A']}, {'name': 'Regimen B calcium and iron/folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women', 'armGroupLabels': ['Regimen B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Chebwayi Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Chegulo Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Chevoso Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Chimoi dispensary', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Chombeli Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Imbiakhalo Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Kimangeti Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Kuvasali Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Malava district hospital', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Manda Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': "Miting'ongo Health centre", 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Mugai Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Namagara Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Shamberere Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Shihome Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}, {'city': 'Kakamega', 'country': 'Kenya', 'facility': 'Shivanga Health centre', 'geoPoint': {'lat': 0.28422, 'lon': 34.75229}}], 'overallOfficials': [{'name': 'Katherine Dickin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kenya Ministry of Health', 'class': 'OTHER_GOV'}, {'name': 'University of Nairobi', 'class': 'OTHER'}, {'name': 'Micronutrient Initiative', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}