An interventional study of 21 micronutrient-fortified supplement and Cereal Fortificado (Fortified Cereal) in Micronutrient Deficiency, sponsored by The Mathile Institute for the Advancement of Human Nutrition. Status unknown at 1 site in El Salvador. Open to participants aged 6 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by The Mathile Institute for the Advancement of Human Nutrition · Not applicable, Interventional, and Treatment
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.
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:
The investigators will test the following hypotheses:
This is the only study on the registry with The Mathile Institute for the Advancement of Human Nutrition as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
21 micronutrient-fortified supplement
Dietary Supplement: 21 micronutrient-fortified supplement
Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A
Dietary Supplement: Cereal Fortificado (Fortified Cereal) · Dietary Supplement: Ferrous sulphate · Dietary Supplement: Vitamin A
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.
Also known as: Chapuditos, M+
"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%.
Also known as: Cereal Fortificado, Supercereal Plus, FBF-V-10
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.
Vitamin A Capsules: children \<12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months.
Changes in mean hemoglobin concentrations
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Monthly from enrollment throughout study completion, and/or until child reaches 60 months of age.
Changes in mean weight-for-height z-scores (WHZ)
Z scores will be calculated based on 2006 child WHO growth standards
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
Length/Height gain/month (cms)
Time frame: 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
Time frame: 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.
Time frame: Monthly after enrollment throughout study completion or until child reaches 60 months of age.
Incidence of Stunting (HAZ<-2SD)
Time frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
Caregiver's practices related to infant and young child feeding, hygiene and sanitation
In a subsample of randomly selected participants infant/child feeding practices will be measured through home observation visits and semi-structured questionnaires.
Time frame: Baseline- 6 months - 12 months - 18 months - 24 months from enrollment.
Milestone development score differences assessed through a developmental milestone scale
A milestone developmental scale that has been adapted to the local context will be implemented every 6 months.
Time frame: Every 6 months after enrollment throughout study completion or until child reaches 60 months of age.
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