Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133419
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-19
Brief Title:
Micronutrients and Enteric Infections in African Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs 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 andor 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None