This trial is active, not recruiting.

Condition anemia
Treatment mnp (micro-nutrient powders)
Sponsor Helen Keller International
Collaborator University of California, Davis
Start date October 2010
End date February 2012
Trial size 334 participants
Trial identifier NCT01488305, 09-000076- AT, MNP impact study


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
(No Intervention)
One arm is control arm, in this arm no additional program is added in government regular program
(No Intervention)
Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities
(No Intervention)
It is actually a intervention arm
mnp (micro-nutrient powders) MNP sub study in AAMA
MNP is added to explore the additional value of MNP in existing AAMA program

Primary Outcomes

time frame: One year

Secondary Outcomes

Impact on growth of children
time frame: one year

Eligibility Criteria

Male or female participants from 6 months up to 23 months old.

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

Additional Information

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
Principal investigator Pooja Pandey Rana, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Helen Keller International.