UndernutritionNPPUNCT01552512
Nutributter Programming to Prevent Undernutrition: an Evaluation
A study testing Nutributter Program and Integrated Package in people with Undernutrition, run by Washington University School of Medicine at 1 site in Haiti.
Trial summary
This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Undernutrition
- What is being tested?
- Nutributter Program and Integrated Package
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 1 siteHaiti
- Study dates
- Jun 2011to Oct 2013
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants 6 to 12 months old
- Lives in Fort San Michel
Who cannot join
- Moderately or severely malnourished
- Peanut allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.
- Conditions
- Undernutrition
- Being tested
- Nutributter Program, Integrated Package
- Keywords
- Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency
- Medical subject headings
- Malnutrition, Growth Disorders, Diarrhea, Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutributter ProgramDietary supplement
Also called Nutriset
Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.
Integrated PackageOther
The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).
| Study group | Role | What they receive |
|---|---|---|
| MSPP Integrated Package | No intervention | Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter. |
| Nutributter 3 Months, Integrated Package | Experimental | Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package. Receives: Dietary Supplement: Nutributter Program; Other: Integrated Package |
| Nutributter 6 Months, Integrated Package | Experimental | Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package. Receives: Dietary Supplement: Nutributter Program; Other: Integrated Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Length for Age
Length (measured in centimeters) for age is an indicator of stunting, an outcome of chronic undernutrition during the first 2 years of life. Because our primary purpose is to prevent undernutrition, we are highly interested in this measurement.
Measured: Once per month for 6 months, then once after 12 months.
Secondary outcomes (1)
Change in Weight for Height
Weight (measured in kilograms) for height (measured in centimeters) is an indicator of moderate to severe acute malnutrition and if an infant is underweight, she/he could require immediate medical attention. We therefore weigh each participant to assess their current health status in this regard.
Measured: Once per month for 6 months, then once after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, World Bank, United Nations World Food Programme (WFP)
- Responsible party
- Sponsor
- Investigators
- Lora Iannotti, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552512
- Sponsor's protocol ID
- FSM-001-201101760
- Acronym
- NPPU
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2012
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iannotti LL, Dulience SJ, Green J, Joseph S, Francois J, Antenor ML, Lesorogol C, Mounce J, Nickerson NM. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. Am J Clin Nutr. 2014 Jan;99(1):198-208. doi: 10.3945/ajcn.113.063883. Epub 2013 Nov 13.
PubMed 24225356
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
- ClinicalTrials.gov ID
- NCT01552512
- Acronym / sponsor ID
- NPPU / FSM-001-201101760
- Conditions
- Undernutrition
- Keywords
- Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of California, Davis, World Bank, United Nations World Food Programme (WFP)
- Study start
- Jun 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Mar 2012 (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.
This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSPP Integrated Package | No intervention | –Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter. |
| Nutributter 3 Months, Integrated Package | Experimental | Dietary Supplement: Nutributter Program, Other: Integrated PackageParticipants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package. |
| Nutributter 6 Months, Integrated Package | Experimental | Dietary Supplement: Nutributter Program, Other: Integrated PackageParticipants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants 6 to 12 months old
- Lives in Fort San Michel
Key exclusion criteria (2 listed)
- Moderately or severely malnourished
- Peanut allergy
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 |
|---|---|---|
| Nutributter ProgramAlso: NutrisetNutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child. | Dietary supplement | Nutributter 3 Months, Integrated Package, Nutributter 6 Months, Integrated Package |
| Integrated PackageThe integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity). | Other | Nutributter 3 Months, Integrated Package, Nutributter 6 Months, Integrated Package |
Primary outcome
Change in Length for Age
Time frame: Once per month for 6 months, then once after 12 months.
Length (measured in centimeters) for age is an indicator of stunting, an outcome of chronic undernutrition during the first 2 years of life. Because our primary purpose is to prevent undernutrition, we are highly interested in this measurement.
1 secondary outcome
Change in Weight for Height
Time frame: Once per month for 6 months, then once after 12 months
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 6 Aug 2018.
- Derived from this study: PubMed 24225356Iannotti LL, Dulience SJ, Green J, Joseph S, Francois J, Antenor ML, Lesorogol C, Mounce J, Nickerson NM. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. Am J Clin Nutr. 2014 Jan;99(1):198-208. doi: 10.3945/ajcn.113.063883. Epub 2013 Nov 13.
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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.
Lora Iannotti, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutributter Program and Integrated Package in people with Undernutrition, run by Washington University School of Medicine at 1 site in Haiti.
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 6 Aug 2018. 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 Haiti. 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?
Change in Length for Age (time frame: Once per month for 6 months, then once after 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552512, which also lists 1 linked publication.
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 6 Aug 2018.