Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments low tocotrienols group, high tocotrienols group
Phase phase 1/phase 2
Sponsor Texas Tech University Health Sciences Center
Collaborator Texas Woman's University
Start date February 2014
End date December 2016
Trial size 78 participants
Trial identifier NCT02058420, American River Nutrition, IRB L14-056

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
No active dose of tocotrienols
(Active Comparator)
Low dose of tocotrienols
low tocotrienols group
300 mg tocotrienols daily
(Active Comparator)
High dose of tocotrienol
high tocotrienols group
600 mg tocotrienols daily

Primary Outcomes

Measure
Serum bone resorption marker
time frame: baseline and after 12 weeks

Secondary Outcomes

Measure
Serum bone formation marker
time frame: baseline, after 6 weeks, after 12 weeks

Eligibility Criteria

Female participants at least 40 years old.

Inclusion criteria 1. Postmenopausal women with no menses for 1-10 years. 2. Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip. 3. 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%. 4. Serum 25-OH vitamin D >= 20 ng/mL. 5. Age 40 and older Exclusion criteria 1. History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD). 2. Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study. 3. Having bisphosphonate within 12 months before the start of the study. 4. Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study. 5. History of cancer except for treated superficial basal or squamous cell carcinoma of the skin. 6. History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols' absorption. 7. Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months. 8. History of statin or other drug for cholesterol-control within 3 months before the start of the study. 9. Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis. 10. 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. 11. Smoking > 10 cigarettes/day. 12. Unwilling to accept randomization.

Additional Information

Official title Effect of Tocotrienols on Bone Health: A Pilot Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center.