Comparison of Two Nutrition Interventions in Young Children in El Salvador

The Mathile Institute for the Advancement of Human Nutrition

Status: Unknown

Conditions: Micronutrient Deficiency

Treatments: Dietary Supplement: Vitamin A; Dietary Supplement: Cereal Fortificado (Fortified Cereal); Dietary Supplement: 21 micronutrient-fortified supplement; Dietary Supplement: Ferrous sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02567981

11-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,577 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,577 participants in 2 patient groups

21 micronutrient fortified supplement

Experimental group

Description:

21 micronutrient-fortified supplement

Treatment:

Dietary Supplement: 21 micronutrient-fortified supplement

Current Standard of Nutritional Care

Active Comparator group

Description:

Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A

Treatment:

Dietary Supplement: Cereal Fortificado (Fortified Cereal)

Dietary Supplement: Vitamin A

Dietary Supplement: Ferrous sulphate