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NCT02058420 · ClinicalTrials.gov registry record · Phase 1
Tocotrienols and Bone Health of Postmenopausal Women
A Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT02058420 is a Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 78 participants.
The verdict
NCT02058420, a Phase 1 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Low tocotrienols group
- DRUG High tocotrienols group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2014-02 |
| Est. Completion | 2022-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02058420
The ClinicalTrials.gov registry entry for NCT02058420 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Tech University Health Sciences Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low tocotrienols group is the first listed.
NCT02058420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02058420 about?
NCT02058420 is a clinical study titled "Tocotrienols and Bone Health of Postmenopausal Women". 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 ha...
What is the current status of trial NCT02058420?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2014-02. Estimated completion is 2022-12.
What interventions are being tested in trial NCT02058420?
The interventions under investigation include: Low tocotrienols group (DRUG), High tocotrienols group (DRUG).
Who is sponsoring clinical trial NCT02058420?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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