Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133406
Status:
UNKNOWN
Last Update Posted:
2011-03-08
First Post:
2005-08-19
Brief Title:
Long-term Impact and Intervention for Diarrhea in Brazil
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Long-term Impact and Intervention for Diarrhea in Brazil
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
RECRUITING
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 primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A Zinc and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score HAZ and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum Study participants will include 280 children ages 2 months to 8 years old with a Height for Age Z score HAZ less than median for the Parque Universitario community living in Brazilian favela There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system
Detailed Description:
Study participants will include 280 children ages 2 months to 8 years old with a Height for Age Z score HAZ less than median for the Parque Universitario community living in Brazilian favela Subjects will be enrolled into this prospective randomized placebo controlled study of the Long-term Impact and Intervention for Diarrhea in Brazil Children meeting the inclusion criteria will be prospectively randomized to four arms 1 placebo placebo 2 Vitamin A Zinc Placebo 3 Vitamin A PlaceboZinc 4 Vitamin AZinc Intervention will last for one year with two additional years of follow up A nested study involving all patients will take place at week four At week four there will be a second randomization to either oral glutamine or glycine placebo for an additional ten days The primary endpoint of the nested study will be the LM ratio at 6 weeks The master randomization list will be broken only by combined approval of the Principal Investigators at the end of the study or in the unexpected event of a child needing removal from the study for that case only All randomized subjects will be visited in their home two times per week for assessment of intercurrent diarrhea At 1 4 8 12 24 and 36 months patients will have a nutritional statusanthropometry and diarrheal illness rate assessment At 0 1 15 and 4 months all randomized subjects will have a LactuloseMannose Ratio LM performed A blood Zinc and Vitamin A level will be drawn at 0 and 4 months Also a stool microbiology lactoferrin and protein loss assessment will be completed at 1 month All randomized subjects who complete the protocol should have assessments as outlined above at 36 weeks The primary effect of interest is the difference in mean HAZ changes between children receiving Zinc plus Vitamin A compared to children receiving no Vitamin A or Zinc averaging the difference in children receiving glutamine and children not receiving glutamine
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 |
|---|---|---|---|
| 05-0071 | OTHER | NIAID | None |