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Trial record 1 of 1 for:    NCT02747524
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Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02747524
First received: April 19, 2016
Last updated: April 27, 2016
Last verified: April 2016
  Purpose

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).


Condition Intervention
Malnutrition Other: Vita Mamba peanut butter paste

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Haiti Rural School Feeding Study: Effects of Vita Mamba on Anemia and Hemoglobin Concentrations

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • hemoglobin concentration [ Time Frame: 26 weeks ]

Enrollment: 321
Study Start Date: November 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vita Mamba
Nutrient fortified peanut butter paste for 26 weeks.
Other: Vita Mamba peanut butter paste
No Intervention: Control

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02747524     History of Changes
Other Study ID Numbers: 201207037
Study First Received: April 19, 2016
Last Updated: April 27, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on June 28, 2017