Back to results

Effects of Omega-3 Fatty Acids on Bone and Frailty

Primary Purpose

Osteoporosis, Frailty

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

DHA/EPA

Placebo capsule

Calcium with vitamin D

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Omega-3 fatty acids, immune response

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Bone turnover markers

Secondary Outcome Measures

Bone Mineral Density

Physical performance measures

Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma

Cognitive status, mood and depression

Full Information

NCT ID

NCT00634686

First Posted

March 11, 2008

Last Updated

January 29, 2009

Sponsor

Donaghue Medical Research Foundation

Collaborators

University of Connecticut

1. Study Identification

Unique Protocol Identification Number

NCT00634686

Brief Title

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

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2009 (Anticipated)

Study Completion Date

June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Donaghue Medical Research Foundation

Collaborators

University of Connecticut

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Frailty

Keywords

Omega-3 fatty acids, immune response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

DHA/EPA

Intervention Description

1.2 gram capsule daily for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo capsule

Intervention Description

daily for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium with vitamin D

Intervention Description

1000 mg of calcium with 1000 IU vitamin D daily for 6 months

Primary Outcome Measure Information:

Title

Bone turnover markers

Time Frame

baseline, 3 and 6 months

Secondary Outcome Measure Information:

Title

Bone Mineral Density

Time Frame

baseline, 3 and 6 months

Title

Physical performance measures

Time Frame

baseline, 3 and 6 months

Title

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

Title

Cognitive status, mood and depression

Time Frame

baseline, 3 and 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Kenny, MD

Organizational Affiliation

University of Connecticut Center on Aging

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10502590

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.

Results Reference

background

PubMed Identifier

11344193

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.

Results Reference

background

PubMed Identifier

9876338

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.

Results Reference

background

Learn more about this trial

Effects of Omega-3 Fatty Acids on Bone and Frailty

We'll reach out to this number within 24 hrs