Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations

NCT02747524 | Completed

• 1 other identifier: 201207037
• Study Type: interventional
• Target: 321
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• hemoglobin concentration

  26 weeks

Study Arms (2)

Vita Mamba

EXPERIMENTAL

Nutrient fortified peanut butter paste for 26 weeks.

Other: Vita Mamba peanut butter paste

Control

NO INTERVENTION

Interventions

Vita Mamba peanut butter paste OTHER

Vita Mamba

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• fever, congenital health condition, or peanut or soy allergy; severely malnourished (weight-for-height \[WHZ\] \<-3)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (1)

• 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.

  PMID: 33822795 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share