NCT02058420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

8.7 years

First QC Date

February 1, 2014

Last Update Submit

February 17, 2023

Conditions

Osteoporosis

Keywords

bone health

Outcome Measures

Primary Outcomes (1)

  • Serum bone resorption marker

    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.

    baseline and after 12 weeks

Secondary Outcomes (1)

  • Serum bone formation marker

    baseline, after 6 weeks, after 12 weeks

Other Outcomes (4)

  • Oxidative stress marker

    baseline, after 6 weeks, after 12 weeks

  • Liver function test

    baseline, after 6 weeks, after 12 weeks

  • Quality of life Survey

    baseline, after 6 weeks, after 12 weeks

  • +1 more other outcomes

Study Arms (3)

Placebo group

NO INTERVENTION

No active dose of tocotrienols

Low tocotrienols group

ACTIVE COMPARATOR

Low dose of tocotrienols

Drug: Low tocotrienols group

High tocotrienols group

ACTIVE COMPARATOR

High dose of tocotrienol

Drug: High tocotrienols group

Interventions

Low tocotrienols groupDRUG

300 mg tocotrienols daily

Low tocotrienols group
High tocotrienols groupDRUG

600 mg tocotrienols daily

High tocotrienols group

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with no menses for 1-10 years.
  • Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip.
  • 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%.
  • Serum 25-OH vitamin D \>= 20 ng/mL.
  • Age 40 and older

You may not qualify if:

  • History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD).
  • Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study.
  • Having bisphosphonate within 12 months before the start of the study.
  • Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study.
  • History of cancer except for treated superficial basal or squamous cell carcinoma of the skin.
  • History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols' absorption.
  • Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months.
  • History of statin or other drug for cholesterol-control within 3 months before the start of the study.
  • Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis.
  • 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.
  • Smoking \> 10 cigarettes/day.
  • Unwilling to accept randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (3)

  • Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0.

    PMID: 29954374DERIVED

  • Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12.

    PMID: 29330573DERIVED

  • Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.

    PMID: 28011809DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2014

First Posted

February 10, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

US(1)