Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT01319734
Status:
UNKNOWN
Last Update Posted:
2013-09-18
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improving the renal function', 'timeFrame': 'the renal function will be measure at day 1 and after one month', 'description': 'vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.'}], 'secondaryOutcomes': [{'measure': 'Vitamin C can improve the visual fields', 'timeFrame': 'the visual field will be assesed at day 1 and after one month', 'description': 'the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'Oxidative stress', 'Type 2DM'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Null hypothesis:\n\nNo significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).\n\nAlternative hypothesis:\n\nThere is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of type 2DM\n* patients in good health\n* receiving oral hypoglycemic drugs\n\nExclusion Criteria:\n\n* Insulin dependent diabetes\n* receiving vitamin complex\n* smoking\n* renal disease\n* liver disease'}, 'identificationModule': {'nctId': 'NCT01319734', 'acronym': 'Vit C', 'briefTitle': 'Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Al-Neelain University'}, 'officialTitle': 'Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications', 'orgStudyIdInfo': {'id': '22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C supplementation plus oral hypoglycemic agents arm', 'description': 'This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.', 'interventionNames': ['Dietary Supplement: Vitamin C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Type 2DM patients receiving oral hypoglycemic agents alone', 'description': 'this group is the control group who receive oral hypoglycemic agents alone', 'interventionNames': ['Drug: glyburide']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin C supplementation 500mg', 'armGroupLabels': ['Vitamin C supplementation plus oral hypoglycemic agents arm']}, {'name': 'glyburide', 'type': 'DRUG', 'description': 'this group receiving glyburide 5 mg alone', 'armGroupLabels': ['Type 2DM patients receiving oral hypoglycemic agents alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1111', 'city': 'Khartoum', 'state': 'Khartoum State', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Khaled H Bakheet, MD,PhD', 'role': 'CONTACT', 'email': 'khalid2_3456@yahoo.com', 'phone': '+249912957764'}, {'name': 'Hamdan Z Hamdan, MBBS,MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jaber abo aliz', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}], 'centralContacts': [{'name': 'Hamdan Z Hamdan, MBBS, Msc', 'role': 'CONTACT', 'email': 'hamdanology@hotmail.com', 'phone': '+249912468264'}, {'name': 'Maha I Mohammed, MBBS, PhD', 'role': 'CONTACT', 'phone': '+249912230895'}], 'overallOfficials': [{'name': 'Hamdan Z Hamdan, MBBS, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Neelain University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Neelain University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Al-Neelain University, Faculty of Medicine, Department of Biochemistry and Molecular biology, Khartoum, Sudan', 'investigatorFullName': 'Hamdan Zaki Hamdan', 'investigatorAffiliation': 'Al-Neelain University'}}}}