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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: Completed Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
NCT02058420 is a Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT02058420 record still lists
NCT02058420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 2 interventions - of which Low tocotrienols group is the first listed.
NCT02058420 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02058420's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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