Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vita Mamba peanut butter paste
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- registration in the study school for 2014-2015 calendar; good health (no fever, congenital health condition, or peanut or soy allergy); and not severely malnourished (weight-for-height [WHZ] <-3)
Exclusion Criteria:
- fever, congenital health condition, or peanut or soy allergy; severely malnourished (weight-for-height [WHZ] <-3)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vita Mamba
Control
Arm Description
Nutrient fortified peanut butter paste for 26 weeks.
Outcomes
Primary Outcome Measures
hemoglobin concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT02747524
First Posted
April 19, 2016
Last Updated
April 27, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02747524
Brief Title
Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations
Official Title
Haiti Rural School Feeding Study: Effects of Vita Mamba on Anemia and Hemoglobin Concentrations
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 1:1 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vita Mamba
Arm Type
Experimental
Arm Description
Nutrient fortified peanut butter paste for 26 weeks.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Vita Mamba peanut butter paste
Primary Outcome Measure Information:
Title
hemoglobin concentration
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
registration in the study school for 2014-2015 calendar; good health (no fever, congenital health condition, or peanut or soy allergy); and not severely malnourished (weight-for-height [WHZ] <-3)
Exclusion Criteria:
fever, congenital health condition, or peanut or soy allergy; severely malnourished (weight-for-height [WHZ] <-3)
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33822795
Citation
Palacios AM, Freeland-Graves JH, Dulience SJ, Delnatus JR, Iannotti LL. Differences in factors associated with anemia in Haitian children from urban and rural areas. PLoS One. 2021 Apr 6;16(4):e0247975. doi: 10.1371/journal.pone.0247975. eCollection 2021.
Results Reference
derived
Learn more about this trial
Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations
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