Comparison of Two Nutrition Interventions in Young Children in El Salvador

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.

Conditions

• Micronutrient Deficiency

Interventions

DIETARY_SUPPLEMENT

21 micronutrient-fortified supplement

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.

DIETARY_SUPPLEMENT

Cereal Fortificado (Fortified Cereal)

"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%.

DIETARY_SUPPLEMENT

Ferrous sulphate

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.

DIETARY_SUPPLEMENT

Vitamin A

Vitamin A Capsules: children \<12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months.

Sponsors & Collaborators

• Fundación Salvadoreña para la Salud y el Desarrollo Humano

  collaborator OTHER

• Humanitas Global Development

  collaborator OTHER

• Ministry of Health, El Salvador

  collaborator OTHER_GOV

• The Mathile Institute for the Advancement of Human Nutrition

  lead OTHER

Principal Investigators

• Gregory A Reinhart, PhD · The Mathile Institute for the Advancement of Human Nutrition

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2020-09-30

Completion

2020-09-30

Countries

• El Salvador

Study Locations