The Role of Multivitamins in Pediatric HIV Management in Nigeria: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 主要终点
- CD4 count
研究概览
简要总结
Micronutrient deficiencies in people living with HIV have been reported. Multivitamins can address micronutrient deficiencies, however the benefits of multivitamins in people living with HIV is still debatable. While some multivitamin intervention studies have reported the benefits of multivitamins in HIV infection, some other studies have reported no statistical differences in outcomes of interest in intervention and control groups. With clear differences in composition and strength of the multivitamins used in the different studies, it is possible that some of the multivitamins used in some of the intervention studies may have been unable to meet existing micronutrient deficiencies. Hence there is a chance that higher strength multivitamins may be better able to correct these deficiencies and result in better outcomes. This study will therefore compare three different multivitamins varying in strength and composition to determine if any one of the three multivitamins will produce better health outcomes.
详细描述
The link between micronutrient deficiencies and advanced HIV disease has been reported. Micronutrient deficiencies in people living with HIV/AIDS (PLWHA) have been linked to reduced antioxidant levels and oxidative stress. In turn oxidative stress is believed to promote HIV disease progression. The use of multivitamins in PLWHA therefore has the potential to cut off the interconnections between micronutrient deficiencies and HIV disease progression. If beneficial, multivitamin use in PLWHA could result in improved health outcomes.
A number of studies have explored this possibility with different results. Differences in multivitamin strength and composition could have been responsible for the different results. Therefore, it is likely that increasing the strength and composition of the intervention multivitamin could possibly produce a single result of improved health outcomes across board. Hence this study will determine if multivitamins at higher strength can cause better health outcomes in study participants compared to lower strength multivitamins.
Multivitamin A is composed of 7 vitamins at recommended daily allowance (RDA), multivitamin B is made up of 22 micronutrients at RDA and multivitamin C is made up of 22 micronutrients at 3 times the RDA. These multivitamins were administered to the 190 study participants in a double blind randomized controlled study to determine if there would be any significant differences in health outcome of participants after 6 months of multivitamin use. All multivitamins regardless of their composition were manufactured to look identical and packaged in identical containers.
This double blind randomized controlled study is being conducted at the HIV treatment centers of the Nigerian Institute of Medical Research and the Lagos State University Teaching Hospital, both in Lagos Nigeria. At the design stage of the study, a feasibility study was carried out at both HIV treatment centers to assess the practicability and potential of success for this study. Following a successful feasibility study, ethical approval was applied for and obtained from each institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5 - 12 years attending the outpatient clinic of the two HIV treatment centers who have tested positive to HIV
- •Children who can return for follow up during the 6 months of the study
- •Children with guardians who can give informed consent -
排除标准
- •Children enrolled in other studies
- •Guardians and children anticipating moving away from the study state
- •Children receiving immunosuppressive therapy
结局指标
主要结局
CD4 count
时间窗: 6 months
A measure of immune competence. CD4 count could range from 500-1500 cells/mm3. Lower values can be seen with advancing HIV disease
次要结局
- Serum zinc levels(6 months)
- Serum Copper levels(6 months)
- Red cell Magnesium(6 months)
- Serum vitamin A levels(6 months)
- Red cell Copper levels(6 months)
- Serum vitamin E levels(6 months)
- Serum selenium levels(6 months)
- Red cell vitamin B6 levels(6 months)
- Red cell manganese levels(6 months)
- Red cell selenium levels(6 months)
- Red cell zinc levels(6 months)
研究者
Regina Esiovwa
PhD Student
University of the West of Scotland