Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 4:38 PM
Study NCT ID:
NCT02585661
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Bioavailability From Dairy Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the isotopic ratio of iron in blood at week 2', 'timeFrame': '14 days after the last stable isotope administration', 'description': 'The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes'}], 'secondaryOutcomes': [{'measure': 'Measurement of plasma ferritin as biomarker of Fe status', 'timeFrame': 'On the 1st day of the stable isotope administration', 'description': 'The plasma ferritin will be measured before the administration of test meal including iron isotopes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds', 'detailedDescription': 'This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.\n\nThe total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-40 years old,\n* Healthy, based on the medical screening visit including a blood formula and biochemistry,\n* Normal BMI for age (18.5-25.0),\n* Weight less than 65 kg,\n* Having obtained informed consent prior trial entry.\n\nExclusion Criteria:\n\n* Anemia or polycythemia respectively evidenced,\n* Significant blood losses over the past 6 months,\n* Plasma ferritin out of 8-50 ug/L range.\n* Any infectious and inflammatory disease in the past four weeks,\n* Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,\n* Known food allergy,\n* Pregnancy (anamnesis) and/or lactation,\n* History of cancer within the past year,\n* Significant weight loss during the last 3 months (5% and more),\n* medication or supplement which may impact red cells count, Hb or Ht\n* Fe supplementation or perfusion in the last three months,\n* Smokers (\\>5 cigarettes),\n* Have a high alcohol consumption (more than 2 drinks/day),\n* Consumption of illicit drugs anamnesis only,\n* Subject having a hierarchical link with the Investigator or co-investigators,\n* Subject who cannot be expected to comply with treatment or study procedure,\n* participating or having participated in another clinical trial during the past month prior to the beginning of this study.'}, 'identificationModule': {'nctId': 'NCT02585661', 'briefTitle': 'Iron Bioavailability From Dairy Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Iron Bioavailability From Fortified Dairy Product in Healthy Women', 'orgStudyIdInfo': {'id': '15.06.MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dairy product + Salt 1', 'description': 'Dairy product fortified with enriched Fe-54 salt (1)', 'interventionNames': ['Dietary Supplement: Dairy product fortified with enriched Fe-54 salt (1)']}, {'type': 'EXPERIMENTAL', 'label': 'Dairy product + Salt 2', 'description': 'Dairy product fortified with enriched Fe-57 salt (2)', 'interventionNames': ['Dietary Supplement: Dairy product fortified with enriched Fe-57 salt (2)']}], 'interventions': [{'name': 'Dairy product fortified with enriched Fe-54 salt (1)', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.5mg of Fe per 100g of product', 'armGroupLabels': ['Dairy product + Salt 1']}, {'name': 'Dairy product fortified with enriched Fe-57 salt (2)', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.5mg of Fe per 100g of product', 'armGroupLabels': ['Dairy product + Salt 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Metabolic Unit, Clinical Development Unit, Nestec', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Maurice Beaumont', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metabolic Unit - Nestec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}