NCT02567981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,577

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

5 years

First QC Date

September 30, 2015

Last Update Submit

November 12, 2019

Conditions

Micronutrient Deficiency

Keywords

chronic undernutritionanemiamicronutrient supplement

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (13)

  • Changes in mean weight-for-height z-scores (WHZ)

    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.

    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.

    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.

    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.

    Every three months after enrollment throughout study completion or until child reaches 60 months of age.

  • +8 more secondary outcomes

Other Outcomes (2)

  • Caregiver's practices related to infant and young child feeding, hygiene and sanitation

    Baseline- 6 months - 12 months - 18 months - 24 months from enrollment.

  • Milestone development score differences assessed through a developmental milestone scale

    Every 6 months after enrollment throughout study completion or until child reaches 60 months of age.

Study Arms (2)

21 micronutrient fortified supplement

EXPERIMENTAL

21 micronutrient-fortified supplement

Dietary Supplement: 21 micronutrient-fortified supplement

Current Standard of Nutritional Care

ACTIVE COMPARATOR

Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A

Dietary Supplement: Cereal Fortificado (Fortified Cereal)Dietary Supplement: Ferrous sulphateDietary Supplement: Vitamin A

Interventions

21 micronutrient-fortified supplementDIETARY_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.

Also known as: Chapuditos, M+
21 micronutrient fortified supplement
Cereal Fortificado (Fortified Cereal)DIETARY_SUPPLEMENT

"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
Current Standard of Nutritional Care
Ferrous sulphateDIETARY_SUPPLEMENT

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.

Current Standard of Nutritional Care
Vitamin ADIETARY_SUPPLEMENT

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

Current Standard of Nutritional Care

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FUSAL

Santa Elena, El Salvador

Location

MeSH Terms

Conditions

Anemia

Interventions

ferrous sulfateVitamin A

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Gregory A Reinhart, PhD

    The Mathile Institute for the Advancement of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 5, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

EL(1)