StuntingNCT03902145
LULUN PROJECT II - Cohort Follow-up Study
An observational study of Stunting, run by Washington University School of Medicine at 1 site in Ecuador.
Trial summary
Child stunting and micronutrient deficiencies are a major problem in developing countries, affecting millions of children. Beginning at 6 months children need foods to complement nutrients received through breastfeeding; however, complementary feeding diets are well-documented to be inadequate in the developing world. Read more about this study
- Who is it for?
- Ages 30 to 36 months
- Conditions the study is for
- Stunting
- What is being tested?
- Egg
- How many people
- 270 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Jun 2017to 31 Aug 2017
- Phase
- Observational
- 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 30 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Lulun Project II is a longitudinal follow-up study of the Lulun Project, which was conducted in Cotopaxi Province, Ecuador.
Who may be able to join
- Participant in the Lulun Project I
- Child healthy, without fever or severely malnourished
Who cannot join
- Child not previously in the Lulun Project I
- Child has fever or is severely malnourished
Trial locations and contacts
1 site in 1 country.
About this study
Child stunting and micronutrient deficiencies are a major problem in developing countries, affecting millions of children.
Beginning at 6 months children need foods to complement nutrients received through breastfeeding; however, complementary feeding diets are well-documented to be inadequate in the developing world. Eggs, which are widely available and low-cost relative to other highly nutritious foods are underutilized and could potentially improve child growth and development. Prior to the Lulun Project RCT, no research had been conducted to evaluate their efficacy in improving micronutrient status. Lulun filled an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B12, lipids, and amino acids in young children in a poor rural area of Ecuador. However, there is still scarce data on how early child complementary feeding interventions, such as the Lulun egg intervention, might impact child growth long-term.
Read more
This study will be designed as a follow-up cohort study to the Lulun Project RCT conducted in Cotopaxi Province from March-December 2015. The proposed follow-up study will investigate the potential long-term impacts of the egg intervention on child growth. Children and mother (caregiver) dyads with endline anthropometric measures from Lulun Project will be invited to participate in the follow-up study. Data will be collected on demographic, socioeconomic, and environmental information, morbidities, and child diet (including egg preparation and consumption), as well as child anthropometry (height, weight, head circumference). Additionally, the study will pilot test and compare radiographic measures of child bone maturity and organ size (kidney, liver, and spleen) using an app-based ultrasound. Investigators from Universidad de San Franscisco de Quito (USFQ), Washington University in St. Louis, and Mathile Institute will collaborate to conduct the study.
This project will also include a gender assessment component designed to ascertain how gender norms may affect prospects for successful scale up of smallholder poultry production. To this end, qualitative data will be collected from a small sample of participating mothers (caregivers) and key community stakeholders, in the form of in-depth interviews and/or focus groups.
Read the detailed description
All mother (caregiver)-child dyads from the Lulun RCT will be contacted by mobile phone and invited to participate. A community meeting will first be held including community leaders and Lulun Project participants to present findings and explain the new follow-up study, Lulun Project II. This will give mothers (caregivers) the opportunity over at least a one week period to decide whether or not to participate and to discuss with family and friends. A field study team consisting of two individuals who participated in first trial and two students from Washington University will then contact mothers or caregivers and asked to come to various community sites used in the Lulun Project. Using processes and protocols from the original trial, mothers (caregivers) will first go through the informed consent and enrollment processes.
Eligibility criteria will include: 1) participant in the Lulun Project I; and 2) child healthy, without fever or severely malnourished. Mothers or primary caregivers of children will be given a written informed consent statement in Spanish to read and sign, indicating their consent and consent on behalf of their child. If the mothers/primary caregiver is less than 18 years of age, informed consent process will be sought from their parents or guardians. Participants with limited literacy will be offered the option to have the statement read to them. Caregivers will be invited to ask any questions about the nature of the study during this time.
For the gender analysis component of the study, a small number (10-20) of prospective mother (caregiver) participants, their partners, and key stakeholders will be contacted by phone by the Field Manager who will explain the nature and (qualitative) method of this part of the study. They will be invited to participate. Consent process for mothers, partners, and community stakeholders will occur after they agree to participate and just prior to interview or focus group.
- Conditions
- Stunting
- Being tested
- Egg
- Keywords
- Complementary Feeding, Animal Source Foods, Bone Age, Stunting, Ecuador, Follow Up Cohort
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EggOther
One egg per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Children previously in the intervention group received one egg per day for 6 months beginning when the child was between 6-9 months of age. Receives: Other: Egg | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height for Age Z-Score
Measured: One time point
Secondary outcomes (5)
Bone Age Z Score
Measured: One time point
Weight for Age Z Score
Measured: One time point
Weight for Height Z Score
Measured: One time point
BMI Z-Score
Measured: One time point
Head Circumference for Age Z-Score
Measured: One time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Jun 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Mathile Institute for the Advancement of Human Nutrition, Universidad San Francisco de Quito, University of California, Davis, RTI International
- Responsible party
- Sponsor
- Investigators
- Lora Iannotti, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902145
- Sponsor's protocol ID
- 201704100
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LULUN PROJECT II - Cohort Follow-up Study
- ClinicalTrials.gov ID
- NCT03902145
- Acronym / sponsor ID
- 201704100
- Conditions
- Stunting
- Keywords
- Complementary Feeding, Animal Source Foods, Bone Age, Stunting, Ecuador, Follow Up Cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Mathile Institute for the Advancement of Human Nutrition, Universidad San Francisco de Quito, University of California, Davis, RTI International
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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.
Child stunting and micronutrient deficiencies are a major problem in developing countries, affecting millions of children.
Beginning at 6 months children need foods to complement nutrients received through breastfeeding; however, complementary feeding diets are well-documented to be inadequate in the developing world. Eggs, which are widely available and low-cost relative to other highly nutritious foods are underutilized and could potentially improve child growth and development. Prior to the Lulun Project RCT, no research had been conducted to evaluate their efficacy in improving micronutrient status. Lulun filled an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B12, lipids, and amino acids in young children in a poor rural area of Ecuador. However, there is still scarce data on how early child complementary feeding interventions, such as the Lulun egg intervention, might impact child growth long-term.
This study will be designed as a follow-up cohort study to the Lulun Project RCT conducted in Cotopaxi Province from March-December 2015. The proposed follow-up study will investigate the potential long-term impacts of the egg intervention on child growth. Children and mother (caregiver) dyads with endline anthropometric measures from Lulun Project will be invited to participate in the follow-up study. Data will be collected on demographic, socioeconomic, and environmental information, morbidities, and child diet (including egg preparation and consumption), as well as child anthropometry (height, weight, head circumference). Additionally, the study will pilot test and compare radiographic measures of child bone maturity and organ size (kidney, liver, and spleen) using an app-based ultrasound. Investigators from Universidad de San Franscisco de Quito (USFQ), Washington University in St. Louis, and Mathile Institute will collaborate to conduct the study.
This project will also include a gender assessment component designed to ascertain how gender norms may affect prospects for successful scale up of smallholder poultry production. To this end, qualitative data will be collected from a small sample of participating mothers (caregivers) and key community stakeholders, in the form of in-depth interviews and/or focus groups.
Detailed description
All mother (caregiver)-child dyads from the Lulun RCT will be contacted by mobile phone and invited to participate. A community meeting will first be held including community leaders and Lulun Project participants to present findings and explain the new follow-up study, Lulun Project II. This will give mothers (caregivers) the opportunity over at least a one week period to decide whether or not to participate and to discuss with family and friends. A field study team consisting of two individuals who participated in first trial and two students from Washington University will then contact mothers or caregivers and asked to come to various community sites used in the Lulun Project. Using processes and protocols from the original trial, mothers (caregivers) will first go through the informed consent and enrollment processes.
Eligibility criteria will include: 1) participant in the Lulun Project I; and 2) child healthy, without fever or severely malnourished. Mothers or primary caregivers of children will be given a written informed consent statement in Spanish to read and sign, indicating their consent and consent on behalf of their child. If the mothers/primary caregiver is less than 18 years of age, informed consent process will be sought from their parents or guardians. Participants with limited literacy will be offered the option to have the statement read to them. Caregivers will be invited to ask any questions about the nature of the study during this time.
For the gender analysis component of the study, a small number (10-20) of prospective mother (caregiver) participants, their partners, and key stakeholders will be contacted by phone by the Field Manager who will explain the nature and (qualitative) method of this part of the study. They will be invited to participate. Consent process for mothers, partners, and community stakeholders will occur after they agree to participate and just prior to interview or focus group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: EggChildren previously in the intervention group received one egg per day for 6 months beginning when the child was between 6-9 months of age. |
| Control Group | – | – |
Who may qualify
- Ages
- 30 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Lulun Project II is a longitudinal follow-up study of the Lulun Project, which was conducted in Cotopaxi Province, Ecuador.
Key inclusion criteria (2 listed)
- Participant in the Lulun Project I
- Child healthy, without fever or severely malnourished
Key exclusion criteria (2 listed)
- Child not previously in the Lulun Project I
- Child has fever or is severely malnourished
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 |
|---|---|---|
| EggOne egg per day for 6 months | Other | Intervention Group |
Primary outcome
Height for Age Z-Score
Time frame: One time point
5 secondary outcomes
Bone Age Z Score
Time frame: One time point
Weight for Age Z Score
Time frame: One time point
Weight for Height Z Score
Time frame: One time point
BMI Z-Score
Time frame: One time point
Head Circumference for Age Z-Score
Time frame: One time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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Evaluation of Children With Endocrine and Metabolic-Related Conditions
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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.
Lora Iannotti, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting, run by Washington University School of Medicine at 1 site in Ecuador.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 Apr 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 Ecuador. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Height for Age Z-Score (time frame: One time point). 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 3 Apr 2019.