Clinical trial NCT02567981: Comparison of Two Nutrition Interventions in Young Children in El Salvador
Official title: Impact of the Consumption of an M+ Fortified Premix (Chapuditos®) in 4 Rural Municipalities in the Department of La Libertad, El Salvador in Children From 6 to 59 Months.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Micronutrient Deficiency
Keywords: chronic undernutrition
anemia
micronutrient supplement
Lead sponsor: The Mathile Institute for the Advancement of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Fundación Salvadoreña para la Salud y el Desarrollo Humano
name: Humanitas Global Development
name: Ministry of Health, El Salvador
First posted: 2015-10-05
Enrollment: 4577
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adequate nutrition during the first years of life is essential to reach full body and brain development potential. Children under the age of 5 in Central America and El Salvador suffer from micronutrient deficiencies. In El Salvador, \~ 20% of children under the age of 5 suffer from chronic undernutrition which is reflected in low length-for-their age Z-scores and anemia. This trial will examine the impact on health and growth in young children that will receive either a 21 micronutrient fortified cereal/legume mix manufactured in Guatemala or the current standard of nutritional care. The ultimate goal is to identify other feasible and effective alternatives to prevent micronutrient deficiencies through culturally acceptable vehicles.

Detailed description: A two-arm nutritional intervention trial utilizing a cluster-randomized design will be implemented in the Department of La Libertad, El Salvador, in children from 6 to 59 months of age for 5 years. One arm of the trial will receive a cereal/legume extruded premix fortified with 21 micronutrients (amounts described in Intervention Type section) and the other arm will continue to receive the current standard of nutritional care that consist of a fortified cereal mix, vitamin A capsules, and prophylactic iron drops.

The monitoring and evaluation of this trial will be integrated to an ongoing program implemented by a local NGO (FUSAL) that aims to reduce poverty and micronutrient deficiencies through a variety of strategies. The nutrition products for children under 24 months of age will be provided by El Salvadoran government health workers at the government's health facilities. FUSAL will also be in charge of distributing food products to children from 24 to 59 months of age on a monthly basis at the community sites.

The trial design includes clusters (census subdivisions with a unique number used by the Government of El Salvador to perform the country's census) that were randomized into one of the two treatments. To evaluate the impact of the nutrition interventions, the trial will have two different types of experimental designs:

1. A repeated cross sectional design: to compare outcomes between groups after 1 year and on a yearly basis until the study is completed.
2. Longitudinal design: children will be followed up over time for at least one year, until they turn 60 months and/or the study is completed, to evaluate incidence and recurrence of anemia, undernutrition and morbidity, and other outcomes.

The investigators will test the following hypotheses:

1. Children receiving the 21 micronutrient fortified supplement will have better health and growth than children receiving the nutritional standard of care.
2. Those who receive the 21 micronutrient fortified supplement until 59 months of age continuously will have better health and growth compared to those who received the nutritional standard of care.
3. The effect of the interventions will be most notable in those children who are stunted/anemic.

Eligibility criteria: Inclusion Criteria:

* Parental signed informed consent.
* Age 6 to 42 months when study begins (so child can be followed up for at least 1 year).
* Permanent resident of selected municipalities and no intention to move for the next two years.
* Availability and commitment to attend well child visits at government health institutions and to comply to FUSAL's "Libras de Amor" program.

Exclusion Criteria:

* Child has severe wasting (weight for height \<-3 z-scores) or any clinical sign/ symptom of severe wasting.
* Child older than 42 months of age when study begins.
* Child has identified conditions that could interfere with their development and growth and/or with severe disease that requires hospital attention.
* Child currently consuming other micronutrient supplements and/or therapeutic foods.
* Child with hemoglobin\<7.9g/dL.
* Child participating in another study or program with a nutrition component.

Primary outcomes:
measure: Changes in mean hemoglobin concentrations
timeFrame: Every six months after enrollment until child reaches 60 months of age or until study completion
measure: Prevalence of anemia
timeFrame: Every six months after enrollment throughout study completion, and/or until child reaches 60 months of age, and/or until study is completed.
measure: Changes in mean length/height-for age z-scores (HAZ)
timeFrame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
measure: Prevalence of stunting defined as HAZ<-2SD below median.
timeFrame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
measure: Incidence of acute respiratory tract infections
timeFrame: Monthly from after enrollment throughout study completion, and/or until child reaches 60 months of age.
measure: Incidence of diarrhea
timeFrame: Monthly from enrollment throughout study completion, and/or until child reaches 60 months of age.
Secondary outcomes:
measure: Changes in mean weight-for-height z-scores (WHZ)
timeFrame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
measure: Prevalence of wasting defined as (WHZ<-2SD) below the median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Incidence of wasting defined as (WHZ<-2SD) below the median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Prevalence of underweight defined as WAZ<-2SD below the median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Incidence of underweight defined as WAZ<-2SD below the median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Changes in mean WAZ
timeFrame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
measure: Prevalence of overweigth defined as BMI-for-age z score>2SD above median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Incidence of overweigth defined as BMI-for-age z score>2SD above median.
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Changes in mean BMI-for-age z score
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Length/Height gain/month (cms)
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Weight gain/month (Kg)
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
measure: Prevalence of respiratory tract infections and of diarrhea
timeFrame: Monthly after enrollment throughout study completion or until child reaches 60 months of age.
measure: Incidence of Stunting (HAZ<-2SD)
timeFrame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
Other outcomes:
measure: Caregiver's practices related to infant and young child feeding, hygiene and sanitation
timeFrame: Baseline- 6 months - 12 months - 18 months - 24 months from enrollment.
measure: Milestone development score differences assessed through a developmental milestone scale
timeFrame: Every 6 months after enrollment throughout study completion or until child reaches 60 months of age.
Locations:
city: Santa Elena
country: El Salvador
facility: FUSAL
Study officials:
affiliation: The Mathile Institute for the Advancement of Human Nutrition
name: Gregory A Reinhart, PhD
role: PRINCIPAL_INVESTIGATOR
References: