Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-06 @ 10:43 PM
Study NCT ID:
NCT02572960
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-04-13', 'releaseDate': '2020-04-01'}], 'estimatedResultsFirstSubmitDate': '2020-04-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aldosterone, before and after 12 weeks of daily cholecalciferol treatment', 'timeFrame': 'Change from baseline p-aldosterone at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Parathyroid hormone, before and after, daily ARB administrations', 'timeFrame': 'Change from baseline p-PTH at 2 weeks'}, {'measure': 'Arterial stiffness', 'timeFrame': 'Change from baseline arterial stiffness at 12 weeks', 'description': 'Spygmocor'}, {'measure': '24 hours arterial stiffness as measured by tonometry', 'timeFrame': 'Change from baseline arterial stiffness PWV at 12 weeks', 'description': 'Arteriograph 24'}, {'measure': '24 hours blood pressure measured by tonometry', 'timeFrame': 'Change from baseline systolic pressure at 12 weeks', 'description': 'Arteriograph 24'}, {'measure': 'Balance as measured by stadiometer (Meitur Ltd)', 'timeFrame': 'Change from postural balance at 12 weeks', 'description': 'Postural stability'}, {'measure': 'Muscle strength as measured by isometric tests', 'timeFrame': 'Change from baseline isometric muscle strength at 12 weeks', 'description': 'Effects on muscle strength (isometric tests of flexion and extension of thigh and hand), two function-tests (timed up-and go and timed stand-and-sit),'}, {'measure': 'Bone density and geometry as measured by QCT scans', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Bone quality in spine and hip as assessed by high resolution quantitative computed tomography HRQCT-scans'}, {'measure': 'Bone density and geometry as measured by HRpQCT scans', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Bone quality in ankle and forearm as assessed by high resolution peripheral quantitative computed tomography HRpQCT-scans'}, {'measure': 'Bone density by DXA', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Bone density assessed by dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Electrocardiogram', 'timeFrame': 'Change from baseline at 2, 6 and 12 weeks', 'description': 'Hearth rhythm, shortened QT interval, hypertrophy'}, {'measure': 'Biomarkers of calcium- and bone metabolism', 'timeFrame': 'Change from baseline at 2, 6 and 12 weeks', 'description': 'Effects of intervention on biochemical markers of calcium and bone metabolism, such as calcium, phosphate, parathyroid hormone, calcitriol, vitamin D-binding protein, bone-specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen (P1NP). Also C-terminal telopeptide of type 1 collagen (CTX) and N-telopeptide of type 1 collagen (NTX) among others.'}, {'measure': 'Quality of Life, SF36', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'SF36v2'}, {'measure': 'Quality of Life, WHO-5', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'WHO-5 well being index'}, {'measure': 'Physical activity', 'timeFrame': 'Change from baseline at 12 weeks', 'description': 'Physical activity scale'}, {'measure': 'Hyperparathyroid symptoms', 'timeFrame': 'Change from baseline at 12 weeks', 'description': "Pasieka's parathyroid symptoms score"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Vitamin D Deficiency', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '35018442', 'type': 'DERIVED', 'citation': 'Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.'}, {'pmid': '30293198', 'type': 'DERIVED', 'citation': 'Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2019 Feb;104(2):160-170. doi: 10.1007/s00223-018-0481-6. Epub 2018 Oct 6.'}, {'pmid': '29931459', 'type': 'DERIVED', 'citation': 'Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Effects of Vitamin D3 Supplementation on Muscle Strength, Mass, and Physical Performance in Women with Vitamin D Insufficiency: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2018 Nov;103(5):483-493. doi: 10.1007/s00223-018-0443-z. Epub 2018 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.', 'detailedDescription': 'In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.\n\nThe purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.\n\nFurthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Secondary hyperparathyroidism due to Vitamin D deficiency\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Renal failure\n* Liver failure\n* Treatment with antihypertensive medication or diuretics\n* Treatment with lithium, NSAID or glucocorticoids\n* Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day\n* Medical treatment for osteoporosis\n* Systolic blood pressure below 120 mmHg\n* Hypercalcaemia (more than 1,33mmol/L)\n* Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis\n* Allergic reaction to ACEi or ARBs.'}, 'identificationModule': {'nctId': 'NCT02572960', 'acronym': 'AldOst', 'briefTitle': 'Physiologic Interactions Between the Adrenal- and the Parathyroid Glands', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Physiologic Interactions Between the Adrenal- and the Parathyroid Glands', 'orgStudyIdInfo': {'id': '2014-LSB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cholecalciferol', 'description': 'Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks', 'interventionNames': ['Dietary Supplement: Cholecalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valsartan', 'description': 'Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks', 'interventionNames': ['Drug: Valsartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks', 'interventionNames': ['Drug: Placebo Valsartan', 'Dietary Supplement: Placebo cholecalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholecalciferol and Valsartan', 'description': 'Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks', 'interventionNames': ['Drug: Valsartan', 'Dietary Supplement: Cholecalciferol']}], 'interventions': [{'name': 'Valsartan', 'type': 'DRUG', 'description': '2 weeks of Valsartan 80 mg per day', 'armGroupLabels': ['Cholecalciferol and Valsartan', 'Valsartan']}, {'name': 'Placebo Valsartan', 'type': 'DRUG', 'description': '2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.', 'armGroupLabels': ['Placebo']}, {'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin D3'], 'description': '12 weeks of daily cholecalciferol treatment, 70 microgram per day', 'armGroupLabels': ['Cholecalciferol', 'Cholecalciferol and Valsartan']}, {'name': 'Placebo cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo D3'], 'description': '12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Endocrinology and Internal Medicine', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Lars Rejnmark, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Endocrinology and Internal medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-04-01', 'type': 'RELEASE'}, {'date': '2020-04-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Aarhus'}}}}