Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02770456
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Oil Supplementation to Pregnant Women in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5531}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premature birth', 'timeFrame': '20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40', 'description': 'Delivery occurring earlier than 259 gestation days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fish oil, preterm birth, pregnancy, China, prevention'], 'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '31387119', 'type': 'DERIVED', 'citation': 'Olsen SF, Halldorsson TI, Li M, Strom M, Mao Y, Che Y, Wang Y, Duan F, Olsen J, Zhou W. Examining the Effect of Fish Oil Supplementation in Chinese Pregnant Women on Gestation Duration and Risk of Preterm Delivery. J Nutr. 2019 Nov 1;149(11):1942-1951. doi: 10.1093/jn/nxz153.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial with fish oil supplementation to pregnant women conducted in areas of China, which are generally low in fish intake and low income, aims at answering the following primary questions:\n\n* Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth\n* Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth\n* Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of spontaneous delivery in the preterm period', 'detailedDescription': 'The basic design is that of a randomized controlled trial with three groups randomized in ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil. Eligible women are randomized at around gestation weeks 16-24 and are asked to take the capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or until they deliver. Women are asked to complete questionnaires at randomization about diet and other baseline information, and again in gestation week 30 and after delivery. The trial is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three randomization groups will be compared with respect to proportions of preterm delivery. Cox regression will be used to compare the groups with respect to rates of spontaneous deliveries while accounting for elective delivery by regarding these as censoring events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy without known complications\n\nExclusion Criteria:\n\n* Regular user of fish oil\n* Regular user of NSAIDs\n* Known twin pregnancy'}, 'identificationModule': {'nctId': 'NCT02770456', 'acronym': 'FOPCHIN', 'briefTitle': 'Fish Oil Supplementation to Pregnant Women in China', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Fetal Programming, Denmark'}, 'officialTitle': 'Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '#6-FY01-317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose fish oil', 'description': 'Women will be offered 4 capsules per day containing fish oil', 'interventionNames': ['Dietary Supplement: High dose fish oil']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose fish oil', 'description': 'Women will be offered 4 capsules per day containing mixed fish oil and olive oil', 'interventionNames': ['Dietary Supplement: Low dose fish oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Women will be offered 4 capsules per day containing olive oil', 'interventionNames': ['Dietary Supplement: Olive oil']}], 'interventions': [{'name': 'High dose fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA', 'armGroupLabels': ['High dose fish oil']}, {'name': 'Low dose fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA', 'armGroupLabels': ['Low dose fish oil']}, {'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sjurdur F Olsen, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Weijin Zhou, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Institute of Planned Parenthood Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Fetal Programming, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Institute of Planned Parenthood Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}