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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Body weight
时间窗: At baseline
Total weight before initiating treatment.
TG 4
时间窗: At week four of treatment
Serum TG measured at week four of treatment.
HD-C 4
时间窗: At week four of treatment
Serum HD-C measured at week four of treatment.
TC 4
时间窗: At week four of treatment
Serum TC measured at week four of treatment.
Low density cholesterol (LD-C)
时间窗: At baseline
Serum LD-C measured at baseline, before initiating treatment
LD-C 4
时间窗: At week four of treatment
Serum LD-C measured at week four of treatment.
HD-C 12
时间窗: At week twelve of treatment
Serum HD-C measured at week twelve of treatment
BMI 12
时间窗: At week twelve of treatment
BMI obtained at week twelve of treatment
Triglycerides (TG)
时间窗: At baseline
Serum TG measured at baseline, before initiating treatment.
Total cholesterol (TC)
时间窗: At baseline
Serum TC measured at baseline, before initiating treatment.
Very low density cholesterol (VLD-C)
时间窗: At baseline
Serum VLD-C measured at baseline, before initiating treatment
Body mass index (BMI)
时间窗: At baseline
BMI obtained before initiating treatment
Weight 4
时间窗: At week four of treatment
Total weight before at week four of treatment.
TG 12
时间窗: At week twelve of treatment
Serum TG measured at week four of treatment.
TC 12
时间窗: At week twelve of treatment
Total serum TG measured at week twelve of treatment
BMI 4
时间窗: At week four of treatment
BMI obtained at week four of treatment
High density cholesterol (HD-C)
时间窗: At baseline
Serum HD-C measured at baseline, before initiating treatment
VLD-C 4
时间窗: At week four of treatment
Serum VLD-C measured at week four of treatment.
VLD-C 12
时间窗: At week twelve of treatment
Serum VLD-C measured at week twelve of treatment
LD-C 12
时间窗: At week twelve of treatment
Serum LD-C measured at week twelve of treatment
Weight 12
时间窗: At week twelve of treatment
Total weight before at week twelve of treatment.
次要结局
未报告次要终点
研究者
Alejandro Gonzalez-Ojeda
MD., Ph.D., F.A.C.S.
Instituto Mexicano del Seguro Social