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Micronutrients and Enteric Infections in African Children

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
National Institute of Allergy and Infectious Diseases (NIAID)

Maneno muhimu

Kikemikali

The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.

Maelezo

A major initiative to reduce the impact of enteric infections on health and nutrition has been micronutrient supplementation. Measures for routine vitamin A and zinc supplementation are gaining increasing support from international agencies, including UNICEF and the WHO. The primary objective of this study is to compare the effect of 3 micronutrient supplements (vitamin A only, vitamin A and zinc, and a micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc) on prevalent days of diarrhea in 3 groups of children (HIV-infected children, HIV-uninfected children born to HIV-infected women, and HIV-uninfected children born to women without HIV infection). The secondary objectives of the study are: (1) to describe the pathogen-specific pattern of enteric infections in both HIV-infected and uninfected children during ages 6-24 months, with a focus on infection with C. parvum and other protozoan pathogens and (2) to conduct a cost-effectiveness analysis of micronutrient supplementation in children aged 6-24 months. The tertiary objectives of the study are: (1) to assess whether either zinc alone or a micronutrient mixture containing zinc affects linear growth and body composition and (2) to determine if infection with specific enteric pathogens is associated with the development of persistent diarrhea lasting > 14 days. The proposed study will be conducted through the African Centre for Health and Population Studies located in Hlabisa Health District, in northern KwaZulu Natal (KZN), South Africa. The study is a randomized, double blind, clinical controlled trial with 3 arms in a study population of infants stratified by HIV status and the HIV status of their mothers. Study participants will include a total of 516 infants aged 4-6 months. The following evaluations will be made throughout the study: (1) blood samples, (2) stool sampling-routine (collected at 6, 12, 18, and 24 months of age), (3) stool sampling-during diarrheal episodes, and (3) lean body mass and anthropometry (assessed at 6, 12, 18, and 24 months of age). Study participants will be involved in study related procedures for up to 18 months.

Tarehe

Imethibitishwa Mwisho: 02/28/2007
Iliyowasilishwa Kwanza: 08/18/2005
Uandikishaji uliokadiriwa Uliwasilishwa: 08/18/2005
Iliyotumwa Kwanza: 08/22/2005
Sasisho la Mwisho Liliwasilishwa: 08/25/2010
Sasisho la Mwisho Lilichapishwa: 08/26/2010
Tarehe ya Kukamilisha Utafiti: 12/31/2005

Hali au ugonjwa

Enteric Infections

Uingiliaji / matibabu

Drug: Vitamin + Zinc + micronutrient mixture

Drug: Vitamin A

Drug: Vitamin A + Zinc

Awamu

Awamu 2

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 4 Months Kwa 4 Months
Jinsia Inastahiki KujifunzaAll
Hupokea Wajitolea wa AfyaNdio
Vigezo

Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials

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