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The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01041521
Recruitment Status : Completed
First Posted : December 31, 2009
Results First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tufts University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions High Triglyceride Level
HIV Infection
Intervention Drug: Lovaza
Enrollment 129
Recruitment Details  
Pre-assignment Details 12 participants were enrolled but the did not participate due to 1) declining to participate, 2) inability of study team to locate participant, or 3) moving out of state.
Arm/Group Title Lovaza (Omega Three Fatty Acid) Sugar Pill
Hide Arm/Group Description

Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months

Other Names:

Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Dietary Supplement: sugar pill

2 capsules given twice daily for 24 months

Period Title: Overall Study
Started 61 56
Completed 44 40
Not Completed 17 16
Arm/Group Title Lovaza (Omega Three Fatty Acid) Sugar Pill Total
Hide Arm/Group Description

Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.

Other Names:

Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months

Dietary Supplement: sugar pill

2 capsules given twice daily Arms: sugar pill

Total of all reporting groups
Overall Number of Baseline Participants 61 56 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 56 participants 117 participants
53  (9) 50  (9) 51  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 56 participants 117 participants
Female
15
  24.6%
10
  17.9%
25
  21.4%
Male
46
  75.4%
46
  82.1%
92
  78.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 56 participants 117 participants
61 56 117
Current smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 56 participants 117 participants
24
  39.3%
16
  28.6%
40
  34.2%
CD4+ cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/cubic mL
Number Analyzed 61 participants 56 participants 117 participants
652  (394) 644  (309) 648  (354)
Undetectable HIV viral load  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 56 participants 117 participants
58
  95.1%
52
  92.9%
110
  94.0%
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/meters squared
Number Analyzed 61 participants 56 participants 117 participants
28  (6) 28  (6) 28  (6)
1.Primary Outcome
Title Triglyceride Level
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lovaza (Omega Three Fatty Acid) Sugar Pill
Hide Arm/Group Description:

Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.

Other Names:

Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months

Dietary Supplement: sugar pill

2 capsules given twice daily Arms: sugar pill

Overall Number of Participants Analyzed 43 40
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
130
(100 to 166)
159
(118 to 233)
2.Secondary Outcome
Title Vascular Function
Hide Description Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lovaza (Omega Three Fatty Acid) Sugar Pill
Hide Arm/Group Description:

Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.

Other Names:

Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months

Dietary Supplement: sugar pill

2 capsules given twice daily Arms: sugar pill

Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: m/s
833  (238) 832  (152)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lovaza (Omega Three Fatty Acid) Sugar Pill
Hide Arm/Group Description

Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.

Other Names:

Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months

Dietary Supplement: sugar pill

2 capsules given twice daily Arms: sugar pill

All-Cause Mortality
Lovaza (Omega Three Fatty Acid) Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Lovaza (Omega Three Fatty Acid) Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/61 (36.07%)      21/56 (37.50%)    
Cardiac disorders     
heart failure   0/61 (0.00%)  0 3/56 (5.36%)  4
myocardial infarction   1/61 (1.64%)  1 1/56 (1.79%)  1
death  [1]  0/61 (0.00%)  0 1/56 (1.79%)  1
chest pain   0/61 (0.00%)  0 3/56 (5.36%)  3
cardiac bypass surgery   1/61 (1.64%)  1 0/56 (0.00%)  0
Endocrine disorders     
diabetic incident   0/61 (0.00%)  0 2/56 (3.57%)  4
hyperglycemia   1/61 (1.64%)  1 0/56 (0.00%)  0
Gastrointestinal disorders     
excessive burping/gas, reflux   2/61 (3.28%)  3 0/56 (0.00%)  0
nausea/vomiting   1/61 (1.64%)  1 2/56 (3.57%)  2
Abdominal pain   1/61 (1.64%)  1 3/56 (5.36%)  3
pancreatitis   0/61 (0.00%)  0 1/56 (1.79%)  1
diverticulitis   0/61 (0.00%)  0 1/56 (1.79%)  1
difficulty swallowing   0/61 (0.00%)  0 1/56 (1.79%)  1
epiglottitis   0/61 (0.00%)  0 1/56 (1.79%)  1
hernia repair   1/61 (1.64%)  1 0/56 (0.00%)  0
General disorders     
elevated triglycerides   1/61 (1.64%)  1 1/56 (1.79%)  1
False positive TB test   1/61 (1.64%)  1 0/56 (0.00%)  0
Pain   1/61 (1.64%)  1 0/56 (0.00%)  0
broken denture   0/61 (0.00%)  0 1/56 (1.79%)  1
Infections and infestations     
sepsis   1/61 (1.64%)  2 0/56 (0.00%)  0
Infection of urinary tract   2/61 (3.28%)  2 1/56 (1.79%)  1
viral gastroenteritis   1/61 (1.64%)  1 0/56 (0.00%)  0
Fever and cough   0/61 (0.00%)  0 1/56 (1.79%)  1
liver infection   0/61 (0.00%)  0 1/56 (1.79%)  1
foot infection   1/61 (1.64%)  1 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders     
orthopedic surgery   1/61 (1.64%)  3 1/56 (1.79%)  1
joint pain   0/61 (0.00%)  0 2/56 (3.57%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
prostate resection due to prostate cancer   1/61 (1.64%)  1 0/56 (0.00%)  0
lung cancer   0/61 (0.00%)  0 1/56 (1.79%)  1
Nervous system disorders     
dizziness   0/61 (0.00%)  0 1/56 (1.79%)  1
stroke   1/61 (1.64%)  1 0/56 (0.00%)  0
tension headache   1/61 (1.64%)  1 0/56 (0.00%)  0
numbness   1/61 (1.64%)  1 1/56 (1.79%)  1
sciatic nerve/muscle spasm   0/61 (0.00%)  0 1/56 (1.79%)  1
syncope   0/61 (0.00%)  0 1/56 (1.79%)  1
concussion   1/61 (1.64%)  1 0/56 (0.00%)  0
confusion   0/61 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
renal failure/elevated creatinine   0/61 (0.00%)  0 2/56 (3.57%)  2
nephrolithiasis   0/61 (0.00%)  0 1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural fluid  [2]  0/61 (0.00%)  0 2/56 (3.57%)  2
pneumonia   5/61 (8.20%)  5 1/56 (1.79%)  1
asthma/shortness of breath   2/61 (3.28%)  2 1/56 (1.79%)  1
acute/chronic bronchitis   0/61 (0.00%)  0 1/56 (1.79%)  1
cocaine-induced bronchospasm   0/61 (0.00%)  0 1/56 (1.79%)  1
Skin and subcutaneous tissue disorders     
rash/eczema   0/61 (0.00%)  0 1/56 (1.79%)  1
Vascular disorders     
Leg swelling or edema   0/61 (0.00%)  0 2/56 (3.57%)  2
Indicates events were collected by systematic assessment
[1]
MI and renal failure
[2]
"fluid around lungs"
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lovaza (Omega Three Fatty Acid) Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/61 (44.26%)      16/56 (28.57%)    
Cardiac disorders     
congestive heart failure   1/61 (1.64%)  1 0/56 (0.00%)  0
Ear and labyrinth disorders     
fluid in ears   1/61 (1.64%)  1 0/56 (0.00%)  0
Endocrine disorders     
Hyperglycemia   1/61 (1.64%)  1 0/56 (0.00%)  0
Gastrointestinal disorders     
excessive gas / burping /bloating   9/61 (14.75%)  10 4/56 (7.14%)  4
abdominal pain   3/61 (4.92%)  3 0/56 (0.00%)  0
Diarrhea or loose stools   8/61 (13.11%)  9 5/56 (8.93%)  5
elevated total bilirubin   0/61 (0.00%)  0 1/56 (1.79%)  1
nausea   6/61 (9.84%)  6 2/56 (3.57%)  2
vomiting   1/61 (1.64%)  1 2/56 (3.57%)  2
General disorders     
body aches   1/61 (1.64%)  1 0/56 (0.00%)  0
surgery (rectal/bladder, hernia)   1/61 (1.64%)  1 1/56 (1.79%)  1
body odor   0/61 (0.00%)  0 1/56 (1.79%)  1
change in taste   1/61 (1.64%)  1 0/56 (0.00%)  0
dehydration   1/61 (1.64%)  1 0/56 (0.00%)  0
fatigue   0/61 (0.00%)  0 1/56 (1.79%)  1
fever   1/61 (1.64%)  1 0/56 (0.00%)  0
Metabolism and nutrition disorders     
increased abdominal fat   1/61 (1.64%)  1 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders     
pain  [1]  2/61 (3.28%)  2 0/56 (0.00%)  0
wrist sprain   0/61 (0.00%)  0 1/56 (1.79%)  1
sacral fracture   0/61 (0.00%)  0 1/56 (1.79%)  1
Nervous system disorders     
concussion   0/61 (0.00%)  0 1/56 (1.79%)  1
fall with loss of consciousness   0/61 (0.00%)  0 1/56 (1.79%)  1
Renal and urinary disorders     
kidney stent   1/61 (1.64%)  1 0/56 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
asthma/pneumonia   1/61 (1.64%)  1 1/56 (1.79%)  1
shortness of breath   0/61 (0.00%)  0 1/56 (1.79%)  1
Skin and subcutaneous tissue disorders     
rash or hives   5/61 (8.20%)  5 4/56 (7.14%)  4
total body itching   0/61 (0.00%)  0 1/56 (1.79%)  1
Vascular disorders     
leg swelling and edema   3/61 (4.92%)  4 2/56 (3.57%)  2
hypertension   0/61 (0.00%)  0 1/56 (1.79%)  1
Indicates events were collected by systematic assessment
[1]
torso above breast
PLEASE NOTE THAT THE PRINCIPLE INVESTIGATOR (CHRISTINE WANKE) HAS LEFT TUFTS UNIVERSITY IN RETIREMENT AND CANNOT BE CONTACTED. PLEASE ALSO NOTE THAT THIS IS NOT AN "APPLICABLE CLINICAL TRIAL". - 9/3/19
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Wanke, Principal Investigator
Organization: Tufts University
EMail: christine.wanke@tufts.edu
Layout table for additonal information
Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01041521    
Other Study ID Numbers: LVZ112667
1R01HL096585-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 30, 2009
First Posted: December 31, 2009
Results First Submitted: March 3, 2017
Results First Posted: February 11, 2020
Last Update Posted: February 11, 2020