Ignite Creation Date:
2024-05-05 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00562874
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2007-11-21
Brief Title:
Nutrition Intervention in Drug Naive HIV-infected Kenyan Women and Their Children
Sponsor:
Indiana University School of Health Rehabilitation Sciences
Organization:
Indiana University
Study Overview
Official Title:
Increasing Animal Source Foods in Diets of HIV-Infected Kenyan Women and Their Children
Status:
COMPLETED
Status Verified Date:
2013-04
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:
HNP
Brief Summary:
Many of the 28 million people with immunodeficiency virus HIV and acquired immunodeficiency syndrome AIDS estimated to be living in sub-Saharan Africa also suffer from malnutrition Reproductive age women their infants and young children are among the most vulnerable for malnutrition and progression of HIV to AIDS and mortality is increased in the malnourished as seen in Eastern and Southern Africa The HIV Nutrition Project HNP research evaluates the effect of protein and micronutrients in meat on the health and nutritional well being of Kenyan women living with HIV in rural Kenya and the health and development of their children by means of a randomized nutrition intervention We will determine if meat in the diets of HIV- infected women and their children 1 protects the immune system and prevents severe infection 2 prevents the loss of body mass and enhances the quality of life among drug naïve women not yet ill enough to warrant antiretroviral drugs and 3 positively impacts growth and development of vulnerable children of the HIV-infected women when compared to those given supplements with the same amount of energy but with either soya or wheat protein The intervention food with beef protein provides significant vitamin B12 lysine and bio-available iron zinc and selenium when compared to the soya and wheat supplements Deficiencies of these nutrients may hasten HIV disease progression
The findings from our project may have implications for the development of initiatives that are either sustainable or subsidized by the local regional andor global economies that ensure that all HIV-infected individuals have access to adequate nutrition support that includes foods that provide enough nutrients that are needed to optimize health and well-being The knowledge gained may significantly impact other populations at high risk for decreased immune function such as those with tuberculosis and malaria
This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4 between 250 and 500 WHO Stage 1 or 2 and with no co-existing infections receive with their child a nutrition biscuit supplement daily 5 daysweek for 12 months These women are not yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food intervention may keep them healthy longer and delay the need for drugs
The findings from our project may have implications for the development of initiatives that are either sustainable or subsidized by the local regional andor global economies that ensure that all HIV-infected individuals have access to adequate nutrition support that includes foods that provide enough nutrients that are needed to optimize health and well-being The knowledge gained may significantly impact other populations at high risk for decreased immune function such as those with tuberculosis and malaria
This is a 3 arm randomized design where 225 HIV-infected rural Kenyan mothers with a CD4 between 250 and 500 WHO Stage 1 or 2 and with no co-existing infections receive with their child a nutrition biscuit supplement daily 5 daysweek for 12 months These women are not yet ill enough to warrant treatment with antiretroviral drugs in Kenya and therefore a food intervention may keep them healthy longer and delay the need for drugs
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCE-G-98-00036-00 | None | None | None |