Effects of Omega-3 Fatty Acids on Bone and Frailty

Study Overview
=================
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.

Official Title
-----------------
Effects of Omega-3 Fatty Acids on Bone and Frailty

Conditions
-----------------
Osteoporosis, Frailty

Intervention / Treatment
-----------------
* Dietary Supplement: DHA/EPA
* Dietary Supplement: Placebo capsule
* Dietary Supplement: Calcium with vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: DHA/EPA<br>* 1.2 gram capsule daily for 6 months<br>Dietary Supplement: Calcium with vitamin D<br>* 1000 mg of calcium with 1000 IU vitamin D daily for 6 months<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo capsule<br>* daily for 6 months<br>Dietary Supplement: Calcium with vitamin D<br>* 1000 mg of calcium with 1000 IU vitamin D daily for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover markers |  | baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Omega-3 fatty acids, immune response