AzTrials
AzTrials

Human Immunodeficiency VirusPhase 3NCT02537236

Omega-3 Supplementation in HIV Patients With Therapeutic Lifestyle Change Diet.

A Phase 3 study testing Omega-3 fatty acids, TLC nutritional intervention and Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention. in people with Human Immunodeficiency Virus, run by Instituto Mexicano del Seguro Social.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and dyslipidemia, wich increase the cardiovascular risk. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Omega-3 fatty acids, TLC nutritional intervention and Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
Jan 2009to Dec 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients positive to Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome
  • Patients older than 18 years positive to HIV/AIDS with HAART
  • Patients who agreed to sign consent under written information
  • Patients that had some type of dyslipidemia according the Mexican Norms of 2002.

Who cannot join

  • Patient with mouth non-permeable
  • Patients with intolerance or allergy to fish oil
  • Patient record in the database SMART but inactive.
  • Patients who use or have used in the last 6 weeks food supplements that modify lipids.
  • Patient who have not attended two of the four set appointments for valuation.

About this study

Official title: Efficacy and Safety of Fish Oil (Omega-3 Fatty Acid) Supplementation With Therapeutic Lifestyle Changes Diet Associated With Lipidic Profile in HIV-positive Patients With Antiretroviral Therapy.

The positive patients to the Human Immunodeficiency Virus (HIV) with Highly Active Antiretroviral Therapy (HAART) present multiple alterations in their corporal composition and dyslipidemia, wich increase the cardiovascular risk.

The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National Cholesterol Education Program on the profile of lipids and the corporal weight in patients with HIV treated with HAART.

Read the detailed description

The infection by Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS), is a chronic condition transmissible and progressive type of viral cause, in which a link is very different between host and virus, which ultimately influences the appearance of opportunistic morbid processes or rare tumors, or both1.

With a prevalence of 3 cases for every 1000 people from 15 to 49 years, Mexico ranks 16th place in the prevalence of HIV/AIDS in adults in Latin America2.

The state of Jalisco, México, occupies the fourth place in terms of positive cases of HIV-AIDS, in this same plane, the municipalities of Guadalajara, Zapopan, Tlaquepaque and Puerto Vallarta in Jalisco, represent the main populations with the highest number of positive cases by HIV-AIDS.

The HIV positive individuals with Highly Active Antiretroviral Therapy (HAART) or without treatment are facing numerous challenges in terms of management of their health; some of the most disturbing changes are visible in the shape and appearance of the body. In most cases this anatomical changes come accompanied by alterations in biochemical indicators: lipid levels (cholesterol and triglycerides) and insulin resistance4.These adverse effects may have important clinical implications, such as severe lactic acidosis, coronary artery disease and acute pancreatitis5.

In patients with HIV and HAART has published an incidence of hypercholesterolemia and hypertriglyceridemia between 5 and 90% depending on the series, although the true incidence is yet to be determined6. Pharmacological interventions with statins or fibrates in patients infected with HIV are limited partially due to the drug interactions and increase in the frequency of adverse effects7.

Therefore, it is necessary to investigate new alternatives for the management of dyslipidemia in patients infected with HIV with HAART through changes in diet and supplements of fish oil omega 3 fatty acids.

Methods Patients: The investigators enrolled 100 Patients positive to Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome, and had been receiving ≥2 Highly Active Antiretroviral Therapy, and with diagnostic of dislipidemia according the Mexican Official Standard Norms of 2002, for the prevention, treatment and control of dyslipidemias8.

All the patients were active in the SMART database from HIV/AIDS department of the Civil Hospital in Guadalajara "Fray Antonio Alcalde". Patients were excluded for intolerance or allergy to fish, patients that use or have used in the last 6 weeks supplements or drugs that modify lipids.

Study design During the period from January 2010 to July 2011, was carried out the study with the authorization of the ethics committee of the Civil Hospital in Guadalajara "Fray Antonio Alcalde".

Our subjects were assigned to 5 intervention groups: Groups one= 20 subjects received Therapeutic Lifestyle Changes diet more 1.05 grams of Fatty Acid omega 3. Groups two= 20 subjects received conventional diet more 1.05 grams of Fatty Acid omega three. Groups 3=20 subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of Fatty Acid omega 3. Groups four=20 subjects received conventional diet more 2.10 grams of Fatty Acid omega 3. Groups five= 20 subjects, control group received conventional diet.

The subject assigned to group one and three with TLC diet, received advice from the nutritionist in week 4 and 12 to encourage the consumption of the capsules of omega 3 fatty acids, in addition offered general recommendations to consume dietary fiber and fluids.

The subject assigned to groups two and four with conventional diet, received advice from the nutritionist in the week 4 and 12 to encourage the consumption of the capsules of omega 3 fatty acids without the assistance of special diet.

The requirements of energy and macronutrients were identified in the patients of group one and three.

None of the subjects received advice on the physical activity that could perform.

Statistical analysis

The main objective of this study was to compare the changes in fasting levels of triglycerides (TG), total cholesterol (TC), high density cholesterol (HD-C), low density cholesterol (LD-C), very low density cholesterol (VLD-C), the body weight and body mass index (BMI) against the week 4 and 12.

The safety and tolerability of the study medication were also secondary outcomes.

Statistical analysis was carried out starting with the Kolmogorov-Smirnov test to identify the distribution of variables, then identify the type of distribution of each variable, is continuous with the descriptive statistical analysis for variables with abnormal distribution -non-parametric, with measures of central tendency and dispersion as: the median distance and interquartiles and variables with normal distribution - parametric- :the mean and standard deviation.

Inferential analysis to the intra-group used the Wilcoxon test and Friedman. For the inferential analysis between groups was implemented in the variables of non-normal distribution, the Kruskal-Wallis test; and for variables with normal distribution was used the one-way ANOVA test. Differences were considered statistically significant when the p value was <0.05 .

The data were processed using the statistical package No.18.0 and are presented in tables and graphics.

Being tested
Omega-3 fatty acids, TLC nutritional intervention, Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Keywords
Omega-3 Fatty Acids, Therapeutic Lifestyle Changes, Human Immunodeficiency Virus, Cardiac Risk, Dyslipidemia
Medical subject headings
Acquired Immunodeficiency Syndrome, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 fatty acidsDietary supplement

    Also called eicosapentaenoic acid, docosahexaenoic acid

    Omega-3 fatty acid supplementation with fish oil.

  • TLC nutritional interventionBehavioural

    nutritional orientation.

  • Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.Dietary supplement

    Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.

Study groups in NCT02537236
Study groupRoleWhat they receive
Group oneExperimental20 subjects received Therapeutic Lifestyle Changes diet more 1.05 grams of fish oil omega 3 fatty acids
Receives: Dietary Supplement: Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Group twoActive comparator20 subjects received conventional diet more 1.05 grams of fish oil omega 3 fatty acids
Receives: Dietary Supplement: Omega-3 fatty acids
Group threeExperimental20 subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of fish oil omega 3 fatty acids.
Receives: Dietary Supplement: Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Group fourActive comparator20 subjects received conventional diet more 2.10 grams of fish oil omega 3 fatty acids
Receives: Dietary Supplement: Omega-3 fatty acids
Group fivePlacebo comparator20 subjects, control group received conventional diet.
Receives: Behavioral: TLC nutritional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Triglycerides (TG)

    Serum TG measured at baseline, before initiating treatment.

    Measured: At baseline

  2. Total cholesterol (TC)

    Serum TC measured at baseline, before initiating treatment.

    Measured: At baseline

  3. High density cholesterol (HD-C)

    Serum HD-C measured at baseline, before initiating treatment

    Measured: At baseline

  4. Low density cholesterol (LD-C)

    Serum LD-C measured at baseline, before initiating treatment

    Measured: At baseline

  5. Very low density cholesterol (VLD-C)

    Serum VLD-C measured at baseline, before initiating treatment

    Measured: At baseline

  6. Body weight

    Total weight before initiating treatment.

    Measured: At baseline

  7. Body mass index (BMI)

    BMI obtained before initiating treatment

    Measured: At baseline

  8. TG 4

    Serum TG measured at week four of treatment.

    Measured: At week four of treatment

  9. TC 4

    Serum TC measured at week four of treatment.

    Measured: At week four of treatment

  10. HD-C 4

    Serum HD-C measured at week four of treatment.

    Measured: At week four of treatment

  11. LD-C 4

    Serum LD-C measured at week four of treatment.

    Measured: At week four of treatment

  12. VLD-C 4

    Serum VLD-C measured at week four of treatment.

    Measured: At week four of treatment

  13. Weight 4

    Total weight before at week four of treatment.

    Measured: At week four of treatment

  14. BMI 4

    BMI obtained at week four of treatment

    Measured: At week four of treatment

  15. TG 12

    Serum TG measured at week four of treatment.

    Measured: At week twelve of treatment

  16. TC 12

    Total serum TG measured at week twelve of treatment

    Measured: At week twelve of treatment

  17. HD-C 12

    Serum HD-C measured at week twelve of treatment

    Measured: At week twelve of treatment

  18. LD-C 12

    Serum LD-C measured at week twelve of treatment

    Measured: At week twelve of treatment

  19. VLD-C 12

    Serum VLD-C measured at week twelve of treatment

    Measured: At week twelve of treatment

  20. Weight 12

    Total weight before at week twelve of treatment.

    Measured: At week twelve of treatment

  21. BMI 12

    BMI obtained at week twelve of treatment

    Measured: At week twelve of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2015 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537236
Sponsor's protocol ID
omega-3-HIV/2009
Status last verified
Aug 2015
First submitted
28 Aug 2015
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8. doi: 10.1097/00002030-199807000-00003.

    PubMed 9619798
  • Mulligan K, Grunfeld C, Tai VW, Algren H, Pang M, Chernoff DN, Lo JC, Schambelan M. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):35-43. doi: 10.1097/00126334-200001010-00005.

    PubMed 10708054
  • Wohl DA, Tien HC, Busby M, Cunningham C, Macintosh B, Napravnik S, Danan E, Donovan K, Hossenipour M, Simpson RJ Jr. Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia. Clin Infect Dis. 2005 Nov 15;41(10):1498-504. doi: 10.1086/497273. Epub 2005 Oct 11.

    PubMed 16231263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3 fatty acids, TLC nutritional intervention and Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention. in people with Human Immunodeficiency Virus, run by Instituto Mexicano del Seguro Social.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Triglycerides (TG) (time frame: At baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537236, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in