MalnutritionNCT03319589
Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
A study testing Supplement in people with Malnutrition, run by Tufts University at 1 site in United States.
Trial summary
This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to generate pilot data for sample size estimates needed for a larger trial. Read more about this study
- Who is it for?
- Ages 24 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jul 2016
- 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 24 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-malnourished children within the 2 villages chosen for study
- Within the specified age range: 24-36 months for young children and 6-7 years for older children, who will also be enrolled in their local school. In the event that researchers cannot enroll at least 15 participants in each age range in each village, will extend the age range up to 35.99 months for young children and up to 6.99 years for older children.
- The family plans to remain in the village for the duration of the study;
- The child does not have any known food allergies as reported by the mother or guardian.
Who cannot join
- If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape or a weight-for-age or height-for-age z-score of less than or equal to -3.0, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to generate pilot data for sample size estimates needed for a larger trial. The study will test the effect of a supplement prepared locally with local and imported ingredients on changes in standard anthropometric benchmarks of growth, cognition, immune function, hemoglobin and skin carotenoids in young children living in 2 villages in rural Guinea-Bissau. Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics. As part of the study, we will assess the feasibility of having local commercial bakers prepare the supplement.
Read the detailed description
Up to 20 children aged 24-30 months and 20 school children aged 6-6.5 years living in each of 2 villages in the Oio region of Guinea-Bissau (total study population up to 80, with no minimum recruitment number) will be recruited for this study, with ages documented by the official birth record, which all families possess. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments. The villages will be broadly comparable in terms of size, affluence, rates of malnutrition, the presence or absence of a school meal program, and tribal affiliation and religion.
One village will be randomly assigned to receive the locally-prepared biscuit and a daily multivitamin and the other will be randomly assigned to be an assessment-only control site. Because this is a pilot study designed to develop methodology for a future powered trial, and the logistics of local supplement preparation need to be developed in advance of the study, the randomization will occur prior to baseline testing to allow for development of infrastructure for supplement preparation. However the villagers will not be informed of the randomization until after baseline testing is complete.
Following baseline measurements of anthropometry, grip strength, cognition, non-invasive measurements of hemoglobin, and skin carotenoids, participants will receive their intervention for 12 weeks and the same measurements taken at baseline will be repeated during the last study week. Since access for the final assessment to villages may be hampered by the rainy season we also request permission to terminate the trial between 9-12 weeks of supplement consumption depending on weather conditions. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.
- Conditions
- Malnutrition
- Being tested
- Supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development
| Study group | Role | What they receive |
|---|---|---|
| Supplement Arm | Experimental | School children (age 6 to 6.5) will receive their supplement 5 days a week in the morning before school starts. They will either receive the supplement at school or at the community health center depending on the preference of the villagers after recruitment. Young children (age 24 to 30 months) will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. Receives: Dietary Supplement: Supplement |
| Control Arm | No intervention | Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive cognitive function
Two measures of executive function, working memory and task-switching abilities, will be administered through play-based games by local research team members. "Spin the Pots" and "Reverse Categorization" tasks, modeled after Carlson et al., have been age modified and culturally adopted.
Measured: Baseline and end line (12 weeks difference)
Secondary outcomes (18)
Supplementation Attendance
community health workers will record attendance of children to consume the supplement.
Measured: Through study completion (12 weeks)
Sicknesses
Community health workers will record sickness (malaria, stomach issues, fever) if children to consume the supplement are unwell.
Measured: Through study completion (12 weeks)
Change in hand grip strength
. In the children aged 6-6.5 years, grip strength in both hands will be measured in duplicate using a dynamometer suitable for pediatric populations
Measured: Baseline and end line (12 weeks difference)
Change in Hemoglobin
Hemoglobin will be measured non-invasively using a standard technique that uses light of different wavelengths directed at the finger
Measured: Baseline and end line (12 weeks difference)
Change in skin carotenoids
a non-invasive optical measure of carotenoids in tissue, measured by shining light in the palm of the hand
Measured: Baseline and end line (12 weeks difference)
Change in immune function
In this study we will measure delayed-type hypersensitivity (DTH) response using a standard Mantoux test composed of 3 antigens and a negative control via 4 intradermal skin injections that will be performed at baseline and the end of the study
Measured: Baseline and end line (12 weeks difference)
Food Product Acceptability
Mothers (for the young children) and school children will be asked on a 4-point scale of '1=not at all' '2=a little', '3=moderately' and '4=very much' how much they enjoy eating the two types biscuits and the multivitamin. Preference for one biscuit over another will be determined by a higher total summed up score. The biscuit with a greater score will be used during the study.
Measured: Baseline
Mother's Height Change
Height of the mothers measured in cm.
Measured: Baseline and end line (12 weeks difference)
Mother's Weight Change
Weight of the mothers measured in kg.
Measured: Baseline and end line (12 weeks difference)
Mother's MUAC change
The weight, height and MUAC of the mothers will also be measured, and family demographic data (family size, number of wives and children and ages) will be collected by questioning the mother.
Measured: Baseline and end line (12 weeks difference)
Family Demographics Change
Family demographic data (family size, number of wives and children and ages) will be collected by questioning the mother.
Measured: Baseline and end line (12 weeks difference)
Photographs
Parents (and children, in the case of the school children) will be asked for permission to take photographs of them that illustrate the outcome measurements and supplement consumption, for the purpose of using in presentations on the research.
Measured: through study completion, 12 weeks
Change in weight
Multiple measurements of weight to ±0.1 kg will be taken using a calibrated digital scale
Measured: Baseline and end line (12 weeks difference)
Change in height
Duplicate measures of height will be made with an upright stadiometer measuring to 0.1 cm
Measured: Baseline and end line (12 weeks difference)
Change in circumferences
Duplicate measurements of mid-upper arm circumference (MUAC) will be taken at the midpoint between the acromion process of scapula and olecranon process, and head circumference will be measured in duplicate at the widest diameter, using standardized World Health Organization (WHO) methods.
Measured: Baseline and end line (12 weeks difference)
Brain Hemoglobin
Near infrared spectroscopy
Measured: Endline at up to 12 weeks
Brain Oxygenation
Near infrared spectroscopy
Measured: Endline at up to 12 weeks
Brain Blood Flow
Near infrared spectroscopy
Measured: Endline at up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startMar 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- International Partnership for Human Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319589
- Sponsor's protocol ID
- 1200
- Status last verified
- Oct 2017
- First submitted
- 11 Mar 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
- ClinicalTrials.gov ID
- NCT03319589
- Acronym / sponsor ID
- 1200
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- International Partnership for Human Development
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Oct 2017 (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.
This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to generate pilot data for sample size estimates needed for a larger trial. The study will test the effect of a supplement prepared locally with local and imported ingredients on changes in standard anthropometric benchmarks of growth, cognition, immune function, hemoglobin and skin carotenoids in young children living in 2 villages in rural Guinea-Bissau. Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics. As part of the study, we will assess the feasibility of having local commercial bakers prepare the supplement.
Detailed description
Up to 20 children aged 24-30 months and 20 school children aged 6-6.5 years living in each of 2 villages in the Oio region of Guinea-Bissau (total study population up to 80, with no minimum recruitment number) will be recruited for this study, with ages documented by the official birth record, which all families possess. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments. The villages will be broadly comparable in terms of size, affluence, rates of malnutrition, the presence or absence of a school meal program, and tribal affiliation and religion.
One village will be randomly assigned to receive the locally-prepared biscuit and a daily multivitamin and the other will be randomly assigned to be an assessment-only control site. Because this is a pilot study designed to develop methodology for a future powered trial, and the logistics of local supplement preparation need to be developed in advance of the study, the randomization will occur prior to baseline testing to allow for development of infrastructure for supplement preparation. However the villagers will not be informed of the randomization until after baseline testing is complete.
Following baseline measurements of anthropometry, grip strength, cognition, non-invasive measurements of hemoglobin, and skin carotenoids, participants will receive their intervention for 12 weeks and the same measurements taken at baseline will be repeated during the last study week. Since access for the final assessment to villages may be hampered by the rainy season we also request permission to terminate the trial between 9-12 weeks of supplement consumption depending on weather conditions. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Arm | Experimental | Dietary Supplement: SupplementSchool children (age 6 to 6.5) will receive their supplement 5 days a week in the morning before school starts. They will either receive the supplement at school or at the community health center depending on the preference of the villagers after recruitment. Young children (age 24 to 30 months) will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. |
| Control Arm | No intervention | –Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics |
Who may qualify
- Ages
- 24 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Non-malnourished children within the 2 villages chosen for study
- Within the specified age range: 24-36 months for young children and 6-7 years for older children, who will also be enrolled in their local school. In the event that researchers cannot enroll at least 15 participants in each age range in each village, will extend the age range up to 35.99 months for young children and up to 6.99 years for older children.
- The family plans to remain in the village for the duration of the study;
- The child does not have any known food allergies as reported by the mother or guardian.
Key exclusion criteria (1 listed)
- If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape or a weight-for-age or height-for-age z-score of less than or equal to -3.0, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic
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 |
|---|---|---|
| Supplementlocally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development | Dietary supplement | Supplement Arm |
Primary outcome
Change in executive cognitive function
Time frame: Baseline and end line (12 weeks difference)
Two measures of executive function, working memory and task-switching abilities, will be administered through play-based games by local research team members. "Spin the Pots" and "Reverse Categorization" tasks, modeled after Carlson et al., have been age modified and culturally adopted.
18 secondary outcomes
Supplementation Attendance
Time frame: Through study completion (12 weeks)
Sicknesses
Time frame: Through study completion (12 weeks)
Change in hand grip strength
Time frame: Baseline and end line (12 weeks difference)
Change in Hemoglobin
Time frame: Baseline and end line (12 weeks difference)
Change in skin carotenoids
Time frame: Baseline and end line (12 weeks difference)
Change in immune function
Time frame: Baseline and end line (12 weeks difference)
Food Product Acceptability
Time frame: Baseline
Mother's Height Change
Time frame: Baseline and end line (12 weeks difference)
Mother's Weight Change
Time frame: Baseline and end line (12 weeks difference)
Mother's MUAC change
Time frame: Baseline and end line (12 weeks difference)
Family Demographics Change
Time frame: Baseline and end line (12 weeks difference)
Photographs
Time frame: through study completion, 12 weeks
Change in weight
Time frame: Baseline and end line (12 weeks difference)
Change in height
Time frame: Baseline and end line (12 weeks difference)
Change in circumferences
Time frame: Baseline and end line (12 weeks difference)
Brain Hemoglobin
Time frame: Endline at up to 12 weeks
Brain Oxygenation
Time frame: Endline at up to 12 weeks
Brain Blood Flow
Time frame: Endline at up to 12 weeks
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 24 Oct 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Malnutrition, run by Tufts University at 1 site in United States.
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 1 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 24 Oct 2017. 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 United States. 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?
Change in executive cognitive function (time frame: Baseline and end line (12 weeks difference)). 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 24 Oct 2017.