Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06276205
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-02-17', 'studyFirstSubmitQcDate': '2024-02-17', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decline in Total Cholesterol', 'timeFrame': '24 weeks', 'description': '\\>9% decline from baseline'}, {'measure': 'Decline in LDL', 'timeFrame': '24 weeks', 'description': '14% decline in LDL-C from baseline \\>14% decline from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levothyroxine', 'Vitamin D', 'Lipids', 'Hypothyroidism', 'Dyslipidemia'], 'conditions': ['Hypothyroidism Primary', 'Lipid Disorder', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.\n\nThe main question it aims to answer is:\n\n• whether adding Vitamin D to standard therapy has any additional benefits\n\nParticipants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.\n\nResearchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of all genders.\n* Age more than 12 years\n* Biochemically hypothyroid (overt \\& subclinical)\n* Vitamin D level between 10-70ng/ml\n* TC \\<250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl\n\nExclusion Criteria:\n\n* Known Atherosclerotic Cardiovascular Disease\n* BMI\\>35kg/m2\n* History of Alcoholism (\\>14 units/day)\n* History of Beta blocker intake\n* Patient taking lipid lowering drugs'}, 'identificationModule': {'nctId': 'NCT06276205', 'acronym': 'ViDaLLiT', 'briefTitle': 'Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism', 'orgStudyIdInfo': {'id': '1037/RC/KEMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D + Levothyroxine', 'interventionNames': ['Drug: Vitamin D', 'Drug: Levothyroxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levothyroxine Alone', 'interventionNames': ['Drug: Levothyroxin']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'if Vitamin D level suboptimal, 50,000 IU/week for 8 weeks followed by 2000 IU/d\n\nif optimal Vitamin D level, 2000 IU/d', 'armGroupLabels': ['Vitamin D + Levothyroxine']}, {'name': 'Levothyroxin', 'type': 'DRUG', 'otherNames': ['Thyroxine'], 'description': 'commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response', 'armGroupLabels': ['Levothyroxine Alone', 'Vitamin D + Levothyroxine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'King Edward Medical University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Endocrinology', 'investigatorFullName': 'Sidrah Lodhi', 'investigatorAffiliation': 'King Edward Medical University'}}}}