Comparison of Two Nutrition Interventions in Young Children in El Salvador

Study Overview
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Brief Summary
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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
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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: A repeated cross sectional design: to compare outcomes between groups after 1 year and on a yearly basis until the study is completed. 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: Children receiving the 21 micronutrient fortified supplement will have better health and growth than children receiving the nutritional standard of care. 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. The effect of the interventions will be most notable in those children who are stunted/anemic.

Official Title
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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.

Conditions
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Micronutrient Deficiency

Intervention / Treatment
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* Dietary Supplement: 21 micronutrient-fortified supplement
* Dietary Supplement: Cereal Fortificado (Fortified Cereal)
* Dietary Supplement: Ferrous sulphate
* Dietary Supplement: Vitamin A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 21 micronutrient fortified supplement<br>21 micronutrient-fortified supplement | Dietary Supplement: 21 micronutrient-fortified supplement<br>* 21 micronutrient fortified supplement: Dose: 18.75g/day. Contains the following daily amounts per dose: Zinc 9 mg, Copper 300mcg, Iron 12mg, Vitamin D 5 mcg, Folic Acid 160mcg, Vitamin E 5mg, Iodine 90mcg, Calcium 200mg, Vitamin A 250mg, Phosphorus 150 mg, Vitamin C 40mg, Magnesium 40mg, Vitamin B12 0.9mcg, Selenium 17mcg, Thiamine 0.5mg, Manganese 0.17mg, Niacin 6mg, Biotin 8mg, Riboflavin 0.5mg, Vitamin B5 1.8mg, Vitamin B6 0.5 mg. Formula (percentage by weight): Maize 64.08%, Soy Beans 30%, Vitamins and Minerals 5.92%, BHA 0.006%. Energy: 73kcal, Protein 4g, Fat 1g, Dietary Fiber 2g, Carbohydrates 12g.<br>* Other names: Chapuditos, M+;|
| Active Comparator: Current Standard of Nutritional Care<br>Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A | Dietary Supplement: Cereal Fortificado (Fortified Cereal)<br>* Cereal Fortificado Dose: 45g/day. Contains the following daily amounts per dose: Vitamin A 226.6mcg, Thiamine 0.058mg, Riboflavin 0.202mg, Niacin 2.16mg, Panthotenic acid 3.015mg, Vitamin B6 0.765mg, Folate 27mcg, Vitamin B12 0.9mg, Vitamin C 45mg, Vitamin D 1.8mcg, Vitamin E 3.735mg, Vitamin K 45mcg, iron 3.6mg, Zinc 1.8mg, Iodine 18mcg, potassium 180mg, phosphorus 90 mg, calcium 58.50mg. Percentage weight: 58% corn, 20% soy, Skim dry milk 8%, Sugar 9%, Soy Oil 3%, Vitamins and Minerals 0.2%, calcium phosphate 1.23%, Potassium chloride 0.27%. Energy 184.5 kcal, protein 7.2%, Fat 4.1%, Fiber 1.4%, Ash 4.6%.<br>* Other names: Cereal Fortificado, Supercereal Plus, FBF-V-10;Dietary Supplement: Ferrous sulphate<br>* Ferrous sulfate drops children <12 months: 12,5mg elemental iron/day (continuous). Children from 12-23.9months: elemental iron 25mg/day (continuous). Chidlren from 24 to 59 months: 1ml/day for two months, every 6 months.<br>Dietary Supplement: Vitamin A<br>* Vitamin A Capsules: children <12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean hemoglobin concentrations |  | Every six months after enrollment until child reaches 60 months of age or until study completion | 
| Prevalence of anemia | Anemia is defined as hemoglobin <11.0g/dL. | Every six months after enrollment throughout study completion, and/or until child reaches 60 months of age, and/or until study is completed. | 
| Changes in mean length/height-for age z-scores (HAZ) | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age. | 
| Prevalence of stunting defined as HAZ<-2SD below median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age. | 
| Incidence of acute respiratory tract infections | Respiratory tract infections definition: any infectious disease of the upper or lower respiratory tract. Caregivers will answer on a monthly basis a brief morbidity questionnaire. | Monthly from after enrollment throughout study completion, and/or until child reaches 60 months of age. | 
| Incidence of diarrhea | Diarrhea definition (WHO):  three or more loose or liquid stools per day (or more frequent passage than is normal for the individual). Termination of an episode is defined when associated symptoms have been absent for more than 48 hours. Caregivers will answer on a monthly basis a brief morbidity questionnaire. | Monthly from enrollment throughout study completion, and/or until child reaches 60 months of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean weight-for-height z-scores (WHZ) | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age. | 
| Prevalence of wasting defined as (WHZ<-2SD) below the median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Incidence of wasting defined as (WHZ<-2SD) below the median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Prevalence of underweight defined as WAZ<-2SD below the median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Incidence of underweight defined as WAZ<-2SD below the median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Changes in mean WAZ | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age. | 
| Prevalence of overweigth defined as BMI-for-age z score>2SD above median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Incidence of overweigth defined as BMI-for-age z score>2SD above median. | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Changes in mean BMI-for-age z score | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Length/Height gain/month (cms) |  | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Weight gain/month (Kg) | Z scores will be calculated based on 2006 child WHO growth standards | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 
| Prevalence of respiratory tract infections and of diarrhea | Caregivers will answer on a monthly basis a brief morbidity questionnaire. Data from health cards will also be recorded. | Monthly after enrollment throughout study completion or until child reaches 60 months of age. | 
| Incidence of Stunting (HAZ<-2SD) |  | Every three months after enrollment throughout study completion or until child reaches 60 months of age. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic undernutrition, anemia, micronutrient supplement