Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT00691418
Status:
WITHDRAWN
Last Update Posted:
2015-03-06
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study
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': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'decision made not to proceed -- no subjects were ever enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is daily intake of 600 mg per day of docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, beginning at 22-24 weeks gestation, associated with increased length of gestation among women who have had a previous preterm delivery?', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['perinatal', 'premature', 'pregnancy', 'gestation'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.', 'detailedDescription': 'We propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future RCT, (c) how many would consent to participate in the RCT, and (d) how many would be subsequently rendered ineligible due to poor compliance. Women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of KPMCP electronic databases (for quantifying outcomes). We hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. Half of these 50-75 women would receive DHA; half would receive placebo.\n\nWe will identify potential subjects based on their response to the Preterm Birth Prevention Program questionnaire (a screening instrument administered by the Regional Perinatal Service Center \\[RPSC\\] to all women in the KPMCP entering prenatal care). Eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned RPSC questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation).\n\nResults of this study will (a) permit us to determine whether an RCT is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an RCT that could address our primary study question.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous preterm delivery (delivery prior to 37 completed weeks of gestation)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00691418', 'briefTitle': 'Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'DHA Administration and Length of Gestation: a Feasibility Study', 'orgStudyIdInfo': {'id': 'KP-Martek01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '600 mg per day of docosahexaenoic acid (DHA)', 'interventionNames': ['Dietary Supplement: docosahexaenoic acid (DHA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'docosahexaenoic acid (DHA)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['omega fatty acid'], 'description': '600 mg per day of docosahexaenoic acid (DHA) starting at 22-24 weeks gestation until delivery.', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'placebo once per day starting at 22-24 weeks gestation until delivery.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gabriel Escobar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}