Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-28 @ 10:39 PM
Study NCT ID:
NCT02058420
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2014-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocotrienols and Bone Health of Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-17', 'releaseDate': '2024-03-22'}, {'resetDate': '2024-07-09', 'releaseDate': '2024-06-14'}, {'resetDate': '2025-03-27', 'releaseDate': '2025-03-27'}, {'resetDate': '2025-09-08', 'releaseDate': '2025-09-05'}], 'estimatedResultsFirstSubmitDate': '2024-03-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2014-02-01', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oxidative stress marker', 'timeFrame': 'baseline, after 6 weeks, after 12 weeks', 'description': "8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α)"}, {'measure': 'Liver function test', 'timeFrame': 'baseline, after 6 weeks, after 12 weeks', 'description': 'serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)'}, {'measure': 'Quality of life Survey', 'timeFrame': 'baseline, after 6 weeks, after 12 weeks', 'description': 'SF-36 survey (v2)'}, {'measure': 'Serum tocotrienols concentrations', 'timeFrame': 'baseline, after 6 weeks, after 12 weeks'}], 'primaryOutcomes': [{'measure': 'Serum bone resorption marker', 'timeFrame': 'baseline and after 12 weeks', 'description': 'serum C-terminal cross-linked telopeptide of type I collagen, CTX Change from baseline CTX at 12 weeks. Investigators will also assess change from baseline CTX at 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Serum bone formation marker', 'timeFrame': 'baseline, after 6 weeks, after 12 weeks', 'description': 'serum N-terminal propeptide of type I collagen, PINP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone health'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '29954374', 'type': 'DERIVED', 'citation': 'Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0.'}, {'pmid': '29330573', 'type': 'DERIVED', 'citation': 'Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12.'}, {'pmid': '28011809', 'type': 'DERIVED', 'citation': 'Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.'}]}, 'descriptionModule': {'briefSummary': 'Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Women are 4 times more likely to have osteoporosis than men because there is no estrogen protection after menopause and women in general have lighter and thinner bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been done the role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss in postmenopausal women. The purpose of the study is to examine the effect of 12-week tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All data will be analyzed statistically.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Postmenopausal women with no menses for 1-10 years.\n2. Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip.\n3. Normal laboratory evaluation, thyroid function: TSH \\> 0.3 and \\< 5.0 mU/L; hepatic function: bilirubin ≤ 2.0 mg/dl; SGOT (also called AST)/SGPT (also called ALT) \\< 3x upper limit of normal; renal function: serum creatinine ≤ 2.0 mg/dl; BUN less than 1.5 times upper limit of normal; serum calcium, phosphorus, and alkaline phosphatase: within normal ranges. HbA1c \\< 7.0%.\n4. Serum 25-OH vitamin D \\>= 20 ng/mL.\n5. Age 40 and older\n\nExclusion criteria\n\n1. History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD).\n2. Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study.\n3. Having bisphosphonate within 12 months before the start of the study.\n4. Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study.\n5. History of cancer except for treated superficial basal or squamous cell carcinoma of the skin.\n6. History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols\' absorption.\n7. Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months.\n8. History of statin or other drug for cholesterol-control within 3 months before the start of the study.\n9. Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis.\n10. Cognitive impairment, depression or other medical/eating disorders, likely to move during the trial, lack of transportation, distance from the study site, or unavailable at sample collection times.\n11. Smoking \\> 10 cigarettes/day.\n12. Unwilling to accept randomization.'}, 'identificationModule': {'nctId': 'NCT02058420', 'briefTitle': 'Tocotrienols and Bone Health of Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center'}, 'officialTitle': 'Effect of Tocotrienols on Bone Health: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB L14-056'}, 'secondaryIdInfos': [{'id': 'American River Nutrition', 'type': 'OTHER', 'domain': 'ARN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo group', 'description': 'No active dose of tocotrienols'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low tocotrienols group', 'description': 'Low dose of tocotrienols', 'interventionNames': ['Drug: Low tocotrienols group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High tocotrienols group', 'description': 'High dose of tocotrienol', 'interventionNames': ['Drug: High tocotrienols group']}], 'interventions': [{'name': 'Low tocotrienols group', 'type': 'DRUG', 'description': '300 mg tocotrienols daily', 'armGroupLabels': ['Low tocotrienols group']}, {'name': 'High tocotrienols group', 'type': 'DRUG', 'description': '600 mg tocotrienols daily', 'armGroupLabels': ['High tocotrienols group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Texas Woman's University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-22', 'type': 'RELEASE'}, {'date': '2024-04-17', 'type': 'RESET'}, {'date': '2024-06-14', 'type': 'RELEASE'}, {'date': '2024-07-09', 'type': 'RESET'}, {'date': '2025-03-27', 'type': 'RELEASE'}, {'date': '2025-03-27', 'type': 'RESET'}, {'date': '2025-09-05', 'type': 'RELEASE'}, {'date': '2025-09-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Texas Tech University Health Sciences Center'}}}}