Micronutrient DeficiencyNCT02567981
Comparison of Two Nutrition Interventions in Young Children in El Salvador
A study testing 21 micronutrient-fortified supplement, Cereal Fortificado (Fortified Cereal) and Ferrous sulphate in people with Micronutrient Deficiency, run by The Mathile Institute for the Advancement of Human Nutrition at 1 site in El Salvador.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiency
- What is being tested?
- 21 micronutrient-fortified supplement, Cereal Fortificado (Fortified Cereal) and Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,577 participants
- Where
- 1 siteEl Salvador
- Study dates
- Sep 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- A repeated cross sectional design: to compare outcomes between groups after 1 year and on a yearly basis until the study is completed.
- 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:
- Children receiving the 21 micronutrient fortified supplement will have better health and growth than children receiving the nutritional standard of care.
- 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.
- The effect of the interventions will be most notable in those children who are stunted/anemic.
- Conditions
- Micronutrient Deficiency
- Being tested
- 21 micronutrient-fortified supplement, Cereal Fortificado (Fortified Cereal), Ferrous sulphate, Vitamin A
- Keywords
- chronic undernutrition, anemia, micronutrient supplement
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21 micronutrient-fortified supplementDietary supplement
Also called Chapuditos, M+
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.
Cereal Fortificado (Fortified Cereal)Dietary supplement
Also called Cereal Fortificado, Supercereal Plus, FBF-V-10
"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%.
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.
Vitamin ADietary supplement
Vitamin A Capsules: children <12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months.
| Study group | Role | What they receive |
|---|---|---|
| 21 micronutrient fortified supplement | Experimental | 21 micronutrient-fortified supplement Receives: Dietary Supplement: 21 micronutrient-fortified supplement |
| Current Standard of Nutritional Care | Active comparator | Cereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A Receives: Dietary Supplement: Cereal Fortificado (Fortified Cereal); Dietary Supplement: Ferrous sulphate; Dietary Supplement: Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean hemoglobin concentrations
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Z scores will be calculated based on 2006 child WHO growth standards
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
Length/Height gain/month (cms)
Measured: 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
Measured: 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.
Measured: Monthly after enrollment throughout study completion or until child reaches 60 months of age.
Incidence of Stunting (HAZ<-2SD)
Measured: Every three months after enrollment throughout study completion or until child reaches 60 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mathile Institute for the Advancement of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Salvadoreña para la Salud y el Desarrollo Humano, Humanitas Global Development, Ministry of Health, El Salvador
- Responsible party
- Sponsor
- Investigators
- Gregory A Reinhart, PhD, Principal investigator, The Mathile Institute for the Advancement of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567981
- Sponsor's protocol ID
- 11-08
- Status last verified
- Nov 2019
- First submitted
- 30 Sep 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02567981
- Acronym / sponsor ID
- 11-08
- Conditions
- Micronutrient Deficiency
- Keywords
- chronic undernutrition, anemia, micronutrient supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,577 participants (actual)
- Lead sponsor
- The Mathile Institute for the Advancement of Human NutritionUniversity, hospital or other
- Collaborators
- Fundación Salvadoreña para la Salud y el Desarrollo Humano, Humanitas Global Development, Ministry of Health, El Salvador
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- A repeated cross sectional design: to compare outcomes between groups after 1 year and on a yearly basis until the study is completed.
- 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:
- Children receiving the 21 micronutrient fortified supplement will have better health and growth than children receiving the nutritional standard of care.
- 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.
- The effect of the interventions will be most notable in those children who are stunted/anemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 21 micronutrient fortified supplement | Experimental | Dietary Supplement: 21 micronutrient-fortified supplement21 micronutrient-fortified supplement |
| Current Standard of Nutritional Care | Active comparator | Dietary Supplement: Cereal Fortificado (Fortified Cereal), Dietary Supplement: Ferrous sulphate, Dietary Supplement: Vitamin ACereal Fortificado (Fortified Cereal) Ferrous sulphate Vitamin A |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 21 micronutrient-fortified supplementAlso: Chapuditos, M+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 | 21 micronutrient fortified supplement |
| Cereal Fortificado (Fortified Cereal)Also: Cereal Fortificado, Supercereal Plus, FBF-V-10"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 | Current Standard of Nutritional Care |
| Ferrous sulphateFerrous 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 | Current Standard of Nutritional Care |
| Vitamin AVitamin A Capsules: children <12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months. | Dietary supplement | Current Standard of Nutritional Care |
Primary outcome
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.
13 secondary outcomes
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.
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.
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.
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.
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.
Changes in mean WAZ
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.
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.
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
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)
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Reinhart, PhD principal investigator
The Mathile Institute for the Advancement of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 21 micronutrient-fortified supplement, Cereal Fortificado (Fortified Cereal) and Ferrous sulphate in people with Micronutrient Deficiency, run by The Mathile Institute for the Advancement of Human Nutrition at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean hemoglobin concentrations (time frame: Every six months after enrollment until child reaches 60 months of age or until study completion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.