Tocotrienols and Bone Health of Postmenopausal Women
Public ClinicalTrials.gov record NCT02058420. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effect of Tocotrienols on Bone Health: A Pilot Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02058420
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2014
- Primary completion
- Sep 30, 2022
- Completion
- Nov 30, 2022
- Last update posted
- Feb 20, 2023
2014 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02058420, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02058420 live on ClinicalTrials.gov.