AnemiaMNPNCT01488305
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study
A study testing MNP (micro-nutrient powders) and AAMA project activities (HFP and IYCF BCC) in people with Anemia, run by Helen Keller International at 1 site in Nepal.
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… Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- MNP (micro-nutrient powders) and AAMA project activities (HFP and IYCF BCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteNepal
- Study dates
- Oct 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 6-9 months of age during enrollment time
- Mothers who want to enroll their children in study
Who cannot join
- Severe anemia
- Children age below six months and age over 23 months during study time
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Anemia
- Being tested
- MNP (micro-nutrient powders), AAMA project activities (HFP and IYCF BCC)
- Keywords
- MNP, AAMA program, Nepal, HFP, IYCF, BCC
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNP (micro-nutrient powders)Dietary supplement
Also called MNP sub study in AAMA
MNP is added to explore the additional value of MNP in existing AAMA program
AAMA project activities (HFP and IYCF BCC)Other
This is the existing AAMA program
| Study group | Role | What they receive |
|---|---|---|
| Only government regular program | No intervention | One arm is control arm, in this arm no additional program is added in government regular program |
| AAMA arm (HFP and IYCF BCC) | Experimental | Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities Receives: Other: AAMA project activities (HFP and IYCF BCC) |
| MNP added in AAMA | Experimental | It is actually a intervention arm Receives: Dietary Supplement: MNP (micro-nutrient powders); Other: AAMA project activities (HFP and IYCF BCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
Measured: One year
Secondary outcomes (1)
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Keller International
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Pooja Pandey Rana, MPH, Principal investigator, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488305
- Sponsor's protocol ID
- 09-000076- AT
- Other IDs
- MNP impact study
- Acronym
- MNP
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01488305
- Acronym / sponsor ID
- MNP / 09-000076- AT
- Conditions
- Anemia
- Keywords
- MNP, AAMA program, Nepal, HFP, IYCF, BCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Helen Keller InternationalUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only government regular program | No intervention | –One arm is control arm, in this arm no additional program is added in government regular program |
| AAMA arm (HFP and IYCF BCC) | Experimental | Other: AAMA project activities (HFP and IYCF BCC)Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities |
| MNP added in AAMA | Experimental | Dietary Supplement: MNP (micro-nutrient powders), Other: AAMA project activities (HFP and IYCF BCC)It is actually a intervention arm |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 6-9 months of age during enrollment time
- Mothers who want to enroll their children in study
Key exclusion criteria (2 listed)
- Severe anemia
- Children age below six months and age over 23 months during study time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNP (micro-nutrient powders)Also: MNP sub study in AAMAMNP is added to explore the additional value of MNP in existing AAMA program | Dietary supplement | MNP added in AAMA |
| AAMA project activities (HFP and IYCF BCC)This is the existing AAMA program | Other | AAMA arm (HFP and IYCF BCC), MNP added in AAMA |
Primary outcome
Anemia
Time frame: One year
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
1 secondary outcome
Impact on growth of children
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Helen Keller internationalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Pandey Rana, MPH principal investigator
Helen Keller International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNP (micro-nutrient powders) and AAMA project activities (HFP and IYCF BCC) in people with Anemia, run by Helen Keller International at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.