Clinical trial NCT00634686: Effects of Omega-3 Fatty Acids on Bone and Frailty
Official title: Effects of Omega-3 Fatty Acids on Bone and Frailty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis
Frailty
Keywords: Omega-3 fatty acids
immune response
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: University of Connecticut
First posted: 2008-03-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bone turnover markers
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: baseline, 3 and 6 months
measure: Physical performance measures
timeFrame: baseline, 3 and 6 months
measure: Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma
timeFrame: baseline, 3 and 6 months
measure: Cognitive status, mood and depression
timeFrame: baseline, 3 and 6 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Connecticut Center on Aging
name: Anne Kenny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401.
citation: Callies F, Fassnacht M, van Vlijmen JC, Koehler I, Huebler D, Seibel MJ, Arlt W, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency: effects on body composition, serum leptin, bone turnover, and exercise capacity. J Clin Endocrinol Metab. 2001 May;86(5):1968-72. doi: 10.1210/jcem.86.5.7483.
citation: Morales AJ, Haubrich RH, Hwang JY, Asakura H, Yen SS. The effect of six months treatment with a 100 mg daily dose of dehydroepiandrosterone (DHEA) on circulating sex steroids, body composition and muscle strength in age-advanced men and women. Clin Endocrinol (Oxf). 1998 Oct;49(4):421-32. doi: 10.1046/j.1365-2265.1998.00507.x.