Trial record 12 of 92 for:    Open Studies | "Vitamin E"

Tocotrienols and Bone Health of Postmenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Texas Tech University Health Sciences Center
Sponsor:
Collaborator:
Texas Woman's University
Information provided by (Responsible Party):
Leslie Shen, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT02058420
First received: February 1, 2014
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Low tocotrienols group
Drug: High tocotrienols group
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Tocotrienols on Bone Health: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Serum bone resorption marker [ Time Frame: baseline and after 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Serum bone formation marker [ Time Frame: baseline, after 6 weeks, after 12 weeks ] [ Designated as safety issue: No ]
    serum N-terminal propeptide of type I collagen, PINP


Other Outcome Measures:
  • Oxidative stress marker [ Time Frame: baseline, after 6 weeks, after 12 weeks ] [ Designated as safety issue: No ]
    8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α)

  • Liver function test [ Time Frame: baseline, after 6 weeks, after 12 weeks ] [ Designated as safety issue: Yes ]
    serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)

  • Quality of life [ Time Frame: baseline, after 6 weeks, after 12 weeks ] [ Designated as safety issue: No ]
    SF-36 survey (v2)

  • Serum tocotrienols concentrations [ Time Frame: baseline, after 6 weeks, after 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058420

Contacts
Contact: Anna Rodriguez, BS 806 743-2533

Locations
United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Chwan-Li (Leslie) Shen, PhD    806-743-2815    Leslie.Shen@ttuhsc.edu   
Principal Investigator: Chwan-Li (Leslie) Shen, PhD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Texas Woman's University
  More Information

No publications provided

Responsible Party: Leslie Shen, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02058420     History of Changes
Other Study ID Numbers: TTUHSC-ARN tocotrienols, American River Nutrition
Study First Received: February 1, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Tech University Health Sciences Center:
bone health

Additional relevant MeSH terms:
Tocotrienols
Vitamin E
Tocopherols
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014