Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02747524
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2016-04-19
Brief Title:
Haiti Rural School Feeding Study Effect of Vita Mamba on Anemia and Hemoglobin Concentrations
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Haiti Rural School Feeding Study Effects of Vita Mamba on Anemia and Hemoglobin Concentrations
Status:
COMPLETED
Status Verified Date:
2016-04
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:
None
Brief Summary:
This study applied a matched cluster controlled design using community cluster as the unit of randomization Communities were first matched during the formative research phase and randomized into treatment Vita Mamba deworming or control deworming groups using a simple experimental 11 design The principal investigator generated the random allocation sequence and assigned the cluster to groups Children were followed longitudinally for Hb concentration and anthropometric measures were taken at baseline November 2014 and endline June 2015 Parents were surveyed at baseline for household-level socioeconomic and demographic information environmental conditions including water hygiene and sanitation and child diet and morbidities
All children in the intervention schools received the Vita Mamba once per school day from November 2014 to June 2015 for approximately 26 weeks Children in both groups received Albendazole at baseline in November 2014 Compliance was monitored by teachers and tracked by collection of empty packages Lessons learned from another school feeding trial by the study team were applied to increase compliance such as opening the packages for the children immediately prior to consumption to discourage selling or sharing later with family members Vita Mamba was developed for the urban school trial by the research team with representatives from Edesia a US-based nonprofit manufacturer of ready-to-use foods with expertise in research and development and Nutriset the parent company in the PlumpyField network Meds Food for Kids a nonprofit manufacturer of ready-to-use foods in Haiti using locally produced peanuts produced the Vita Mamba for this trial Vita Mamba 50 g contains 260 kcal and meets 75 of the Recommended Dietary Allowance RDA for critical micronutrients S1 Table
All children in the intervention schools received the Vita Mamba once per school day from November 2014 to June 2015 for approximately 26 weeks Children in both groups received Albendazole at baseline in November 2014 Compliance was monitored by teachers and tracked by collection of empty packages Lessons learned from another school feeding trial by the study team were applied to increase compliance such as opening the packages for the children immediately prior to consumption to discourage selling or sharing later with family members Vita Mamba was developed for the urban school trial by the research team with representatives from Edesia a US-based nonprofit manufacturer of ready-to-use foods with expertise in research and development and Nutriset the parent company in the PlumpyField network Meds Food for Kids a nonprofit manufacturer of ready-to-use foods in Haiti using locally produced peanuts produced the Vita Mamba for this trial Vita Mamba 50 g contains 260 kcal and meets 75 of the Recommended Dietary Allowance RDA for critical micronutrients S1 Table
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