Different Strategies for Preventing Severe Acute Malnutrition in Niger

Malnutrition Clinical Trial

Official title:

Different Strategies for Preventing Severe Acute Malnutrition in Niger: a Pragmatic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828814
• Other study ID #: Epicentre
• Status: Completed
• Phase: N/A
• First received: March 4, 2013
• Last updated: April 27, 2017
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2017
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7836
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• resident in selected villages

• height between 60 and 80 cm.

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Locations

Country	Name	City	State
Niger	Villages	Madarounfa	Maradi

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe acute malnutrition	Severe acute malnutrition was defined as : Weight for Height Z-score (WHO Standards 2006)< -3 and/or mid-upper arm circumference (MUAC) < 115mm and/or bipedal oedema. MUAC was measured at the midpoint of a child's left arm with a plastic measuring tape with a precision of 1 mm.; These indicators were evaluated monthly during the entire follow-up (15 months).	15 months
Secondary	Mortality	Mortality events include all reports for which the cause for absence from surveillance visits was reported to be death by a family member.	duration of follow-up (15 months)