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临床试验/CTRI/2016/03/006774
CTRI/2016/03/006774已完成不适用

Evaluating the effect of nutritional supplementation combined with counselling on nutritional recovery in immuno-compromised children

Rotary Club Aurangabad and Mahim Mumbai1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Increase in weight height and improvement in immunity of study group with respect to control

研究概览

简要总结

Background: In India, infected children constitute 4.4 percent of all people living with Human Immunodeficiency Virus, HIV. HIV and malnourishment creates a vicious cycle that eventually weakens the immune system further. It leads to poor nutrition, weight loss, muscle wasting, weakness and nutrient deficiency, impairing the immune system and reducing the ability to fight the virus. It also increases the risk of other infections due to an increased oxidative stress. Chronic oxidative state can affect immune systems fight against HIV, possibly by: increasing the production of HIV, weakening the immune system, making T cells destroy themselves, causing cells to make abnormal chemicals and making the body more sensitive to toxic effect of certain drugs. An increased damage wherein reactive oxygen intermediates called free radicals are generated may cause damage to cell membranes, proteins and nucleic acids, resulting in stores naturally occurring antioxidant reducing agents being depleted. Progressive oxidative stress and increased lipid peroxidation induced by the production of reactive oxygen species play a critical role in HIV replication and immunodeficiency. Such damage may be prevented or moderated by a normal antioxidant defence system that scavenges by reactive oxygen species. Antioxidants Vit. A, C, and E were found to be low in HIV infected children with respect to uninfected children due to an increase in utilization of antioxidant micronutrients-increased oxidative stress caused by free radicals. HIV-infected children are prone for malnutrition and are vulnerable for high mortality rate. Malondialdehyde, MDA, is an enzyme that is a marker of oxidative stress in the body.

Aims and Objectives: To determine the effectiveness of nutritional supplementation on nutritional and biochemical parameters, assess the acceptability and palatability of multigrain mix supplementation; evaluate impact on CD4 counts with supplementation and to compare the levels of antioxidants in immune-compromised children before and after giving supplementation.

Materials and Methods: Open prospective interventional case control study at the Pediatric Centre of Excellence for HIV Care at a tertiary care institution. Hundred patients, 50 in the study group consuming nutritional  laddoos and receiving counselling, and 50 in the control group receiving only nutritional counselling, were enrolled and follow up was done for 6 months after laddoos were stopped for both the study and control group, so as to keep track of their change in weight, height and other clinical parameters. Special investigations like Vitamin C and MDA levels were monitored in 10 patients from the study group and control group each.

**Study Duration:**October 2013 to August 2015.

Inclusion Criteria: 6 months to 15-year old children with HIV infection, fulfilling Moderate Acute Malnutrition MAM criteria; under nutrition as per the WHO, yet not on ART and 6 months to 15-year old children with HIV infection who are on ART but having failure to gain weight on 2 consecutive visits.

Exclusion Criteria: Patients already on vitamin/ mineral or any other nutritional supplementation.

**Results:**Out of 100 patients in the study and control group, 37 were female and 63, male. Majority of the children belonged to the age group 12 to 15 years, followed by 9 to 12 years, 6 to 9 years, 3 to 6 years and 0 to 3 years. Thirty-seven patients from the study group were on ART and 13, not on ART whereas 42 patients from the control group were on ART and 8 not on ART. The mean weight gain and increase in height was significantly more in the study group, p less than 0.001, for a duration of 6 months for which they consumed nutritional laddoos, with respect to the control group. When the laddoos were stopped, the mean weight gain of the study group was insignificant with respect to the control group. However, the rate of weight gain was 8 times that of the control group, 8.21 gm per day and 1.05 gm per day respectively, at the end of 1 year. The CD4 count was seen to steadily increase in the study group whereas was seen to drop in the control group over a period of 1 year. The change in clinical staging was also more significant, p less than 0.001, in the study group compared to control group. Majority of the patients, 17 consumed only 20 to 40 percent of the laddoos required by them based on their weight and height, followed by 14 who consumed 80 to100 percent of the laddoos. The Vitamin C levels increased more significantly in the study group compared to the control group and the MDA levels dropped in the study group whereas continued to rise in the control group.

**Conclusion:**This study provides a vital combination of protein and essential micronutrients and has proven to cause in increase in nutrition; weight, height and immunity of HIV-infected, MAM children. It runs parallel to the previous evidence found in literature and goes a long way in giving the HIV-infected children a better chance to lead a normal life and contribute to society.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
6.00 Month(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 6 months to 15 yr old children with HIV infection fulfilling Moderate Acute Malnutrition MAM criteria and under nutrition as per WHO definition yet not on ART 6 months to 15 yr old children wit HIV infection who are on ART and fulfill MAM criteria but have failed to gain weight in 2 consecutive visits 1 month apart.

排除标准

  • Patients already on vitamin mineral or any other nutritional supplementation.

结局指标

主要结局

Increase in weight height and improvement in immunity of study group with respect to control

时间窗: Enrollment October 2013 to August 2014 | Follow up August 2014 to May 2015 | Analysis May 2015 to August 2015

Vitamin C levels increased in the study group with respect to control

时间窗: Enrollment October 2013 to August 2014 | Follow up August 2014 to May 2015 | Analysis May 2015 to August 2015

次要结局

  • Vitamin C levels increased in the study group with respect to control(Enrollment October 2013 to August 2014)

研究者

发起方
Rotary Club Aurangabad and Mahim Mumbai
申办方类型
Other [ngo]

研究点 (1)

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