Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study

Anemia Clinical Trial

— MNP  

Official title:

Impact of Micronutrient Powders (MNP)With Homestead Food Production and an Intensive Community Level IYCF-BCC Intervention on Reducing Anemia and Improving Growth in Young Children, Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488305
• Other study ID #: 09-000076- AT
• Secondary ID: MNP impact study
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2011
• Source: Helen Keller International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helen Keller International (HKI), the ministry of health and population, and ministry of agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO) partners are currently implementing a USAID funded Action Against Malnutrition Through Agriculture (AAMA) project in Baitadi district located in far Western development region of Nepal. HKI is undertaking this study within the AAMA project to test whether providing micro-nutrient powders (MNPs) in a programmatic context along with homestead food production (HFP) and an intensive community level Infant and Young Child Feeding Behavior change communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and improving growth in young children than only providing the HFP and IYCF-BCC intervention without MNPs or a control with no intervention.

Description:

The AAMA project uses the homestead food production (HFP) model that focuses on increasing households year round access to nutritious food as a platform to deliver a proven essential nutrition actions (ENA) related messages to household with children less than 2 years old. The AAMA project seeks to examine the effects of household level HFP on malnutrition. So the recipient and other partners wishes to undertake a study to explore a plausible delivery mechanism for MNPs along with HFP and intensive community level IYCF-BCC and their impact on infant/child growth and anemia.

The study is a cluster randomized controlled trial with a three arm factorial design. The trial involve 330 randomly selected children aged 6-9 months at the time of enrollment (n=110 per each of the three study arms). MNPs distributed through FCHVs to 110 children selected from communities that already have the HFP and IYCF-BCC intervention. This group of children will be compared on outcome parameters for anemia, growth (stunting, underweight and wasting) and infections (diarrhea, fever and cough) to a similar sub-set of children (n=110) who receive only the HFP and IYCF-BCC intervention and to a third sub-set of control children of similar age (n=110) who are not receiving either of these interventions. Children aged 6-9 months were chosen for the study because this age range captures the recommended age for introduction of complementary foods to children and our chosen age group also falls within the 0-24 month age range which is considered the period of rapid growth and development and therefore period of highest nutrient requirements in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• Children 6-9 months of age during enrollment time

• Mothers who want to enroll their children in study

Exclusion Criteria:

• Severe anemia

• Children age below six months and age over 23 months during study time

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• MNP (micro-nutrient powders)
MNP is added to explore the additional value of MNP in existing AAMA program

Other:
• AAMA project activities (HFP and IYCF BCC)
This is the existing AAMA program

Locations

Country	Name	City	State
Nepal	Helen Keller International, Nepal	Baitadi

Sponsors (2)

Lead Sponsor	Collaborator
Helen Keller International	University of California, Davis

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)	One year
Secondary	Impact on growth of children	Assess the growth of children (wasting, underweigh and stunting)after one year of MNP distribution (MNP distribution started in March 2011)	one year

External Links

•   Helen Keller international