This trial is active, not recruiting.

Conditions osteoporosis, frailty
Treatments dha/epa, placebo capsule, calcium with vitamin d
Phase phase 4
Sponsor Donaghue Medical Research Foundation
Collaborator University of Connecticut
Start date January 2007
End date June 2009
Trial size 150 participants
Trial identifier NCT00634686, AG0096


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
1.2 gram capsule daily for 6 months
calcium with vitamin d
1000 mg of calcium with 1000 IU vitamin D daily for 6 months
(Placebo Comparator)
placebo capsule
daily for 6 months
calcium with vitamin d
1000 mg of calcium with 1000 IU vitamin D daily for 6 months

Primary Outcomes

Bone turnover markers
time frame: baseline, 3 and 6 months

Secondary Outcomes

Bone Mineral Density
time frame: baseline, 3 and 6 months
Physical performance measures
time frame: baseline, 3 and 6 months
Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma
time frame: baseline, 3 and 6 months
Cognitive status, mood and depression
time frame: baseline, 3 and 6 months

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title Effects of Omega-3 Fatty Acids on Bone and Frailty
Principal investigator Anne Kenny, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by National Institute on Aging (NIA).