Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-27 @ 10:21 AM
Study NCT ID:
NCT02373033
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Folate-Rich Foods Improve Folate Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005494', 'term': 'Folic Acid Deficiency'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma folate', 'timeFrame': '(0 and 12 weeks)', 'description': 'Assessment of plasma folate at baseline, 8 and 12 weeks'}, {'measure': 'Change in erythrocyte folate', 'timeFrame': '(0 and 12 weeks)', 'description': 'Assessment of erythrocyte folate at baseline, 8 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in plasma total homocysteine', 'timeFrame': '(0 and 12 weeks)', 'description': 'Assessment of plasma total homocysteine at baseline, 8 and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Folate', 'folic acid', 'intervention trial', 'folate status', 'women in childbearing age', 'food folate'], 'conditions': ['Folic Acid Deficiency']}, 'referencesModule': {'references': [{'pmid': '19190070', 'type': 'RESULT', 'citation': 'Ohrvik VE, Olsson JC, Sundberg BE, Witthoft CM. Effect of 2 pieces of nutritional advice on folate status in Swedish women: a randomized controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1053-8. doi: 10.3945/ajcn.2008.27192. Epub 2009 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.', 'detailedDescription': 'Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special diets (vegetarian), not pregnant, not planning conception or not lactating.\n\nA randomized, controlled, parallel intervention trial with two active groups and one blinded control group was carried out for 12 weeks (March to June, 2013). The active food group (n = 21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice, providing additional 250 μg/d folate); the active folic acid supplement group consumed a supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received apple juice containing no folate or folic acid) in addition to the freely chosen diet.\n\nFasted venous blood samples were collected at baseline, two months and three months for quantification of folate in plasma and erythrocytes and of homocysteine in plasma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNormal biochemical range for:\n\n* Fasted plasma glucose\n* Iron status (haemoglobin, serum ferritin)\n* Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)\n* Lipid profile (triglycerides, LDL, HDL)\n* Folate status (plasma and erythrocyte folate)\n* Plasma total homocysteine (tHcy)\n* Vitamin B-12\n\nExclusion Criteria:\n\n* History of acute or chronic disease\n* Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)\n* A body mass index (BMI, in kg/m2) \\>18 and \\<30\n* Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation'}, 'identificationModule': {'nctId': 'NCT02373033', 'acronym': 'Folatefood', 'briefTitle': 'Folate-Rich Foods Improve Folate Status', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women', 'orgStudyIdInfo': {'id': 'Formas Sida Dn 222-2009-1975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Natural food folate', 'description': 'Food group consumed folate-rich foods (providing additional 250 μg/d folate).', 'interventionNames': ['Other: Natural food folate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Folic acid', 'description': 'Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).', 'interventionNames': ['Other: Folic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intervention: Control', 'description': 'Control group received apple juice containing no folate or folic acid every day.', 'interventionNames': ['Other: Apple juice']}], 'interventions': [{'name': 'Natural food folate', 'type': 'OTHER', 'otherNames': ['Food folate'], 'description': 'Consumed folate-rich foods (providing additional 250 μg/d folate).', 'armGroupLabels': ['Intervention: Natural food folate']}, {'name': 'Folic acid', 'type': 'OTHER', 'description': 'Received a folic acid supplement (providing additional 500 μg/d folic acid).', 'armGroupLabels': ['Intervention: Folic acid']}, {'name': 'Apple juice', 'type': 'OTHER', 'description': 'Received apple juice containing no folate or folic acid.', 'armGroupLabels': ['Intervention: Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Cornelia Witthöft, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Food Science, Swedish University of Agricultural Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish University of Agricultural Sciences', 'class': 'OTHER'}, {'name': 'The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohammed Hefni', 'investigatorAffiliation': 'Mansoura University'}}}}