Frailty, Osteoporosis
Conditions
Keywords
Omega-3 fatty acids, immune response
Brief summary
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.
Detailed description
Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.
Interventions
DIETARY_SUPPLEMENTDHA/EPA
1.2 gram capsule daily for 6 months
DIETARY_SUPPLEMENTPlacebo capsule
daily for 6 months
DIETARY_SUPPLEMENTCalcium with vitamin D
1000 mg of calcium with 1000 IU vitamin D daily for 6 months
Sponsors
University of Connecticut
Donaghue Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal women over 65 years old * Spine or hip bone density T score less than -1 * Hand grip strength 2 standard deviations below weight adjusted norms * Able to travel to the clinical sites for follow-up visits
Exclusion criteria
* Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism) * Cancer of any kind (except basal or squamous cell of skin) in past 5 years. * Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months * Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time * Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation * Estimated creatinine clearance less than 50 ml/min * History of chronic liver disease or evidence of liver disease on screening * History of hip fracture or known vertebral fracture within the past year * Untreated hypertension or a history of clotting disorders * History of allergy to fish or fish oil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone turnover markers | baseline, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Bone Mineral Density | baseline, 3 and 6 months |
| Physical performance measures | baseline, 3 and 6 months |
| Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma | baseline, 3 and 6 months |
| Cognitive status, mood and depression | baseline, 3 and 6 months |
Countries
United States
Outcome results
None listed