NCT02808117

Brief Summary

This study will analyze data from a program run by an microfinance institution (MFI) in Haiti from 2011-2012 where the MFI delivered health goods to some of the villages where it operates. By comparing health indicators among children who were in villages targeted by the program initially to children who were in villages that were not targeted by the program until later, the investigators hope to understand if the MFI successfully delivered the intervention and offer a practical platform for delivery of basic health goods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

June 17, 2016

Last Update Submit

November 29, 2016

Conditions

MalnutritionAnemia

Keywords

microfinance institutionMFI

Outcome Measures

Primary Outcomes (1)

  • Change in blood hemoglobin concentration

    Baseline, 3 months

Secondary Outcomes (1)

  • Prevalence of diagnosis of anemia

    3 months

Study Arms (2)

Targeted initially

Children who were in the Haiti villages and targeted by the MFI program with MNP delivery initially.

Dietary Supplement: MNP

Targeted later

Children who were in the Haiti villages and not targeted by the MFI program with MNP delivery until later.

Dietary Supplement: MNP

Interventions

MNPDIETARY_SUPPLEMENT

Program that delivered MNP and implemented by an MFI in Haiti during 2011-2012. One form of micronutrient supplementation proven to effectively combat micronutrient deficiency.

Also known as: Micronutrient powders, Sprinkles
Targeted initiallyTargeted later

Eligibility Criteria

Age6 Months - 54 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 6-54 months who lived in a household where the head of household was an microfinance client.

You may qualify if:

  • Lives in a household where the head of household was an microfinance client.

You may not qualify if:

  • Severely anemic (Hgb \< 70 g/L)
  • Severely malnourished (Mid Upper Arm Circumference \< 110 mm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

MalnutritionAnemia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Aaron I Baum, PhD

    Columbia University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

May 1, 2015

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

US(1)