Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-28 @ 7:46 PM
Study NCT ID:
NCT01894295
Status:
UNKNOWN
Last Update Posted:
2013-07-10
First Post:
2013-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003314', 'term': 'Corn Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of ACS and FASN Enzymes', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Measurement by ELISA kit'}], 'primaryOutcomes': [{'measure': 'Resting Metabolic Rate', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Measurement by indirect calorimetry.'}], 'secondaryOutcomes': [{'measure': 'Changes of Nesfatin-1, PPARγ and PGC1α protein levels', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'Measurement by ELISA kit'}]}, 'conditionsModule': {'keywords': ['Vitamin D analogues', 'Resting Metabolic rate', 'obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. Moreover, the investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 22-52 years Body mass index equal or more than 30\n\nExclusion Criteria:\n\nAcute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug'}, 'identificationModule': {'nctId': 'NCT01894295', 'briefTitle': 'Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '91-03-27-18831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D analogue', 'description': '1-α hydroxyvitamin D3; dose 0.25, 0.5 and 1 microgram.', 'interventionNames': ['Dietary Supplement: Vitamin D analogue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Corn oil pearl Capsules 1 gram', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['corn oil capsule'], 'description': 'Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Vitamin D analogue', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['1-α hydroxyvitamin D3'], 'description': '1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks', 'armGroupLabels': ['Vitamin D analogue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Mahmoud Jalali, PhD', 'role': 'CONTACT', 'email': 'jalalimahmoud@hotmail.com'}, {'name': 'Khadijeh Mirzaei, MS', 'role': 'CONTACT', 'email': 'mina_mirzaei101@yahoo.com'}], 'facility': 'TehranUMS', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Mahmoud Jalali, Phd', 'role': 'CONTACT', 'email': 'jalalimahmoud@hotmail.com', 'phone': '+982188954911'}, {'name': 'Khadijeh Mirzaei, MS', 'role': 'CONTACT', 'email': 'mina_mirzaei101@yahoo.com', 'phone': '+989124379670'}], 'overallOfficials': [{'name': 'Mahmoud Jalali, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tehran University of Medical Sciences'}, {'name': 'Khadijeh Mirzaei, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}