Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT02058420
Eligibility 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT02058420
Study Brief:
Protocol Section:
NCT02058420