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Comparison of Two Nutrition Interventions in Young Children in El Salvador

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ClinicalTrials.gov Identifier: NCT02567981
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : November 7, 2016
Sponsor:
Collaborators:
Fundación Salvadoreña para la Salud y el Desarrollo Humano
Humanitas Global Development
Ministry of Health, El Salvador
Information provided by (Responsible Party):
The Mathile Institute for the Advancement of Human Nutrition

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.

Condition or disease Intervention/treatment Phase
Micronutrient Deficiency Dietary Supplement: 21 micronutrient-fortified supplement Dietary Supplement: Cereal Fortificado (Fortified Cereal) Dietary Supplement: Ferrous sulphate Dietary Supplement: Vitamin A Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: 21 micronutrient fortified supplement
21 micronutrient-fortified supplement
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.
Other Name: Chapuditos, M+

Active Comparator: Current Standard of Nutritional Care
Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A
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%.
Other Name: Cereal Fortificado, Supercereal Plus, FBF-V-10

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.




Primary Outcome Measures :
  1. Changes in mean hemoglobin concentrations [ Time Frame: Every six months after enrollment until child reaches 60 months of age or until study completion ]
  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.



Secondary Outcome Measures :
  1. Changes in mean weight-for-height z-scores (WHZ) [ 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

  2. Prevalence of wasting defined as (WHZ<-2SD) below the median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  3. Incidence of wasting defined as (WHZ<-2SD) below the median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  4. Prevalence of underweight defined as WAZ<-2SD below the median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  5. Incidence of underweight defined as WAZ<-2SD below the median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  6. Changes in mean WAZ [ 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

  7. Prevalence of overweigth defined as BMI-for-age z score>2SD above median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  8. Incidence of overweigth defined as BMI-for-age z score>2SD above median. [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  9. Changes in mean BMI-for-age z score [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  10. Length/Height gain/month (cms) [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
  11. Weight gain/month (Kg) [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]
    Z scores will be calculated based on 2006 child WHO growth standards

  12. Prevalence of respiratory tract infections and of diarrhea [ Time Frame: Monthly after enrollment throughout study completion or until child reaches 60 months of age. ]
    Caregivers will answer on a monthly basis a brief morbidity questionnaire. Data from health cards will also be recorded.

  13. Incidence of Stunting (HAZ<-2SD) [ Time Frame: Every three months after enrollment throughout study completion or until child reaches 60 months of age. ]

Other Outcome Measures:
  1. Caregiver's practices related to infant and young child feeding, hygiene and sanitation [ Time Frame: Baseline- 6 months - 12 months - 18 months - 24 months from enrollment. ]
    In a subsample of randomly selected participants infant/child feeding practices will be measured through home observation visits and semi-structured questionnaires.

  2. Milestone development score differences assessed through a developmental milestone scale [ Time Frame: Every 6 months after enrollment throughout study completion or until child reaches 60 months of age. ]
    A milestone developmental scale that has been adapted to the local context will be implemented every 6 months.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567981


Contacts
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Contact: Ana M Palacios, MD 937.245.6180 ana.palacios@mathileinstitute.org

Locations
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El Salvador
FUSAL Recruiting
Santa Elena, El Salvador
Contact: María J Dominguez, BA    (503) 2241-6900      
Sponsors and Collaborators
The Mathile Institute for the Advancement of Human Nutrition
Fundación Salvadoreña para la Salud y el Desarrollo Humano
Humanitas Global Development
Ministry of Health, El Salvador
Investigators
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Principal Investigator: Gregory A Reinhart, PhD The Mathile Institute for the Advancement of Human Nutrition

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Responsible Party: The Mathile Institute for the Advancement of Human Nutrition
ClinicalTrials.gov Identifier: NCT02567981     History of Changes
Other Study ID Numbers: 11-08
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by The Mathile Institute for the Advancement of Human Nutrition:
chronic undernutrition
anemia
micronutrient supplement

Additional relevant MeSH terms:
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Vitamins
Vitamin A
Micronutrients
Retinol palmitate
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents