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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02808117
Other study ID # AAAP7004
Secondary ID
Status Completed
Phase N/A
First received June 17, 2016
Last updated November 29, 2016
Start date May 2015
Est. completion date November 2016

Study information

Verified date November 2016
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Two-thirds of child deaths could be prevented with increased coverage of existing health products and services; however, effectively delivering health products and services to rural populations in low-income countries remains a practical challenge. This study investigates whether microfinance institutions (MFIs), having invested in community-based infrastructure to deliver financial services to 200 million rural poor households globally, offer a practical platform for delivery of basic health goods.

The investigators intend to analyze data from a pilot program implemented by an MFI in Haiti during 2011-2012 that distributed an evidence-based health good, micronutrient powders (MNPs), to 526 children in 34 villages where the MFI operates. Micronutrient deficiency is estimated to be responsible for over 1 million deaths of children under five per year. MNPs are one form of micronutrient supplementation proven to effectively combat micronutrient deficiency.

Published cost estimates indicate that leveraging existing supply chains could cut the total cost of mass MNP delivery by 25%. Given MFIs reach 200 million households globally, MFI-based delivery of health goods may be a promising route to improving health outcomes efficiently.


Recruitment information / eligibility

Status Completed
Enrollment 526
Est. completion date November 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 54 Months
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Severely anemic (Hgb < 70 g/L)

- Severely malnourished (Mid Upper Arm Circumference < 110 mm)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MNP
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.

Locations

Country Name City State
United States Columbia University New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood hemoglobin concentration Baseline, 3 months No
Secondary Prevalence of diagnosis of anemia 3 months No
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