NCT02567981

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.

Status unknown NA Last updated 12 November 2019

What this trial tests

NA trial testing 21 micronutrient-fortified supplement in Micronutrient Deficiency in 4,577 participants. Status unknown.

Timeline

1 September 2015

Primary endpoint
1 September 2020

1 September 2020

Quick facts

Lead sponsor	The Mathile Institute for the Advancement of Human Nutrition
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	4,577
Start date	1 September 2015
Primary completion	1 September 2020
Estimated completion	1 September 2020
Sites	1 location across El Salvador

Drugs / interventions tested

• 21 micronutrient-fortified supplement
• Cereal Fortificado (Fortified Cereal)
• Ferrous sulphate — full drug profile →
• Vitamin A — full drug profile →

Conditions studied

• Micronutrient Deficiency — all drugs for Micronutrient Deficiency →

Sponsor

The Mathile Institute for the Advancement of Human Nutrition

Who can join

Adults 6 Months to 59 Months, any sex, with Micronutrient Deficiency. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  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.
  Anemia is defined as hemoglobin \<11.0g/dL.
• Changes in mean length/height-for age z-scores (HAZ)
  Time frame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
  Z scores will be calculated based on 2006 child WHO growth standards
• Prevalence of stunting defined as HAZ<-2SD below median.
  Time frame: Every three months after enrollment throughout study completion, and/or until child reaches 60 months of age.
  Z scores will be calculated based on 2006 child WHO growth standards
• Incidence of acute respiratory tract infections
  Time frame: Monthly from after enrollment throughout study completion, and/or until child reaches 60 months of age.
  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.
• Incidence of diarrhea
  Time frame: Monthly from enrollment throughout study completion, and/or until child reaches 60 months of age.
  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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integrated Nutrition Program Improves Anemia and Hemoglobin Concentrations in 6- to 12-Month-Old Infants From Rural El Salvador
   · 2021