Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02921204
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2016-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intake and Vitamin D Level in Adult Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-30', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exposure to sun', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Vitamin D serum levels', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Calcium serum levels', 'timeFrame': '1 year'}, {'measure': 'Vitamin D and Calcium Intake', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D', 'Calcium', 'Phytic Acid', 'body weight'], 'conditions': ['Deficiency of Vitamin D3']}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency is most diagnosed among women living in the Kingdom of Saudi Arabia. Many factors have been attributed to the incidence of vitamin D deficiency. Saudi women are thought to be at greater risk for vitamin D deficiency because of their darker skin type and the likelihood of reduced ultraviolet exposure . The present study entitled, "Dietary Intake and Vitamin D Level in adult Women," was formulated as there is paucity of data on the etiologic importance of dietary intake in Vitamin D level on blood on women. The major objective of the proposed study is to assess the effect of dietary intake of nutrients and level of vitamin D in women .', 'detailedDescription': 'For this study, the investigators enrolled 168 women 35-55 years old to evaluate Vitamin D status and to determined whether status was correlated with Vitamin D deficiency.\n\nAll women completed a self-administered questionnaire about personal socio-demographic characteristics; They all had anthropometric measurements of body mass index and waist circumference. A 24-hour dietary recall was administered to all women.\n\nThe proximate analysis of 25 types of food was conducted according to the American Association of Organic Chemists (AOAC) methods. The following parameters were measured: serum calcium. Vitamin D, levels of parathyroid hormone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pre and post-menopausal women 35-55 years of age who were able to provide a 24 hour dietary record.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 35- 55 years old,\n* Women who spoke Arabic language fluently, and\n* Women who were willing to fill a 24-hour questionnaire and provide a serum sample for measurements.\n\nExclusion Criteria:\n\n* Women \\< 35 years old or \\> 55 years old.'}, 'identificationModule': {'nctId': 'NCT02921204', 'acronym': 'VDAW', 'briefTitle': 'Dietary Intake and Vitamin D Level in Adult Women', 'organization': {'class': 'OTHER', 'fullName': 'Princess Nourah Bint Abdulrahman University'}, 'officialTitle': 'Study is to Assess the Effect of Dietary Intake of Nutrients and Level of Vitamin D in Women', 'orgStudyIdInfo': {'id': 'NON'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitamin D status', 'description': 'Subjects are recruited to asses Vitamin D status with no interventions', 'interventionNames': ['Other: Vitamin D status']}], 'interventions': [{'name': 'Vitamin D status', 'type': 'OTHER', 'description': 'There is no intervention in this study', 'armGroupLabels': ['Vitamin D status']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amani Aljajani, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Nourah Bint Abdulrahman University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Nourah Bint Abdulrahman University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Connecticut', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profossor', 'investigatorFullName': 'Nora ALfaris', 'investigatorAffiliation': 'Princess Nourah Bint Abdulrahman University'}}}}