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Tocotrienols and Bone Health of Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02058420
Recruitment Status : Active, not recruiting
First Posted : February 10, 2014
Last Update Posted : March 2, 2022
Texas Woman's University
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Low tocotrienols group Drug: High tocotrienols group Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Tocotrienols on Bone Health: A Pilot Study
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Placebo group
No active dose of tocotrienols
Active Comparator: Low tocotrienols group
Low dose of tocotrienols
Drug: Low tocotrienols group
300 mg tocotrienols daily

Active Comparator: High tocotrienols group
High dose of tocotrienol
Drug: High tocotrienols group
600 mg tocotrienols daily

Primary Outcome Measures :
  1. Serum bone resorption marker [ Time Frame: baseline and after 12 weeks ]
    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.

Secondary Outcome Measures :
  1. Serum bone formation marker [ Time Frame: baseline, after 6 weeks, after 12 weeks ]
    serum N-terminal propeptide of type I collagen, PINP

Other Outcome Measures:
  1. Oxidative stress marker [ Time Frame: baseline, after 6 weeks, after 12 weeks ]
    8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α)

  2. Liver function test [ Time Frame: baseline, after 6 weeks, after 12 weeks ]
    serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)

  3. Quality of life Survey [ Time Frame: baseline, after 6 weeks, after 12 weeks ]
    SF-36 survey (v2)

  4. Serum tocotrienols concentrations [ Time Frame: baseline, after 6 weeks, after 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02058420

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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Texas Woman's University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Texas Tech University Health Sciences Center Identifier: NCT02058420    
Other Study ID Numbers: IRB L14-056
American River Nutrition ( Other Identifier: ARN )
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Keywords provided by Texas Tech University Health Sciences Center:
bone health
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs