Complementary FeedingPhase 3First BitesNCT01084109
First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
A Phase 3 study testing Lyophilized meat and Cereal in people with Complementary Feeding and Infant Growth, run by NICHD Global Network for Women's and Children's Health at 4 sites in 4 countries.
Trial summary
The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease… Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Complementary Feeding, Infant Growth
- What is being tested?
- Lyophilized meat and Cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,236 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 3
- 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 3 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year < -2) of at least 20% in young children.
- Infant aged 3-4 months;
- Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year.
Who cannot join
- Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.
- Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:
- known congenital anomaly;
- infant of multiple births;
- known neurological deficit apparent at the time of enrollment (including seizures).
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Guatemala1 site
Institute for Nutrition of Central America and Panama (INCAP)
Chiimaltenango
Republic of the Congo1 site
Kinshasa School of Public Health
Karawa
About this study
Official title: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.
Read the detailed description
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages. Participants from four sites in the Global Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; as necessary the food intervention and messages will be delivered at home by the assigned community coordinator or alternate. Outcome measures, obtained by a separate group of local, trained assessment workers, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.
- Conditions
- Complementary Feeding, Infant Growth
- Being tested
- Lyophilized meat, Cereal
- Keywords
- Complementary feeding, Infant growth, Developing countries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized meatOther
Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)
CerealOther
Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) Receives: Other: Lyophilized meat |
| 2 | Active comparator | Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months. Receives: Other: Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth velocity
Measured: 6 to 18 months of age
Secondary outcomes (3)
Infant Zinc and Ferritin levels
Measured: 18 months
Bayleys II
Measured: 18 months
Incidence of diarrhea, lower respiratory infection, and malaria
Measured: 6 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complementary FeedingStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Kinshasa School of Public Health, University of Zambia, INCAP, Chiimaltenango, Guatemala, Aga Khan University, University of Colorado, Denver, University of North Carolina, Chapel Hill, University of Alabama at Birmingham, Drexel University, RTI International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084109
- Sponsor's protocol ID
- GN CF
- Acronym
- First Bites
- Status last verified
- Nov 2013
- First submitted
- 9 Mar 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manasyan A, Salas AA, Nolen T, Chomba E, Mazariegos M, Tshefu Kitoto A, Saleem S, Naqvi F, Hambidge KM, Goco N, McClure EM, Wallander JL, Biasini FJ, Goldenberg RL, Bose CL, Koso-Thomas M, Krebs NF, Carlo WA. Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries. BMJ Open. 2023 May 23;13(5):e065076. doi: 10.1136/bmjopen-2022-065076.
PubMed 37221030Krebs NF, Mazariegos M, Chomba E, Sami N, Pasha O, Tshefu A, Carlo WA, Goldenberg RL, Bose CL, Wright LL, Koso-Thomas M, Goco N, Kindem M, McClure EM, Westcott J, Garces A, Lokangaka A, Manasyan A, Imenda E, Hartwell TD, Hambidge KM. Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings. Am J Clin Nutr. 2012 Oct;96(4):840-7. doi: 10.3945/ajcn.112.041962. Epub 2012 Sep 5.
PubMed 22952176Krebs NF, Hambidge KM, Mazariegos M, Westcott J, Goco N, Wright LL, Koso-Thomas M, Tshefu A, Bose C, Pasha O, Goldenberg R, Chomba E, Carlo W, Kindem M, Das A, Hartwell T, McClure E; Complementary Feeding Study Group. Complementary feeding: a Global Network cluster randomized controlled trial. BMC Pediatr. 2011 Jan 13;11:4. doi: 10.1186/1471-2431-11-4.
PubMed 21232139
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01084109
- Acronym / sponsor ID
- First Bites / GN CF
- Conditions
- Complementary Feeding, Infant Growth
- Keywords
- Complementary feeding, Infant growth, Developing countries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Kinshasa School of Public Health, University of Zambia, INCAP, Chiimaltenango, Guatemala, Aga Khan University, University of Colorado, Denver, University of North Carolina, Chapel Hill, University of Alabama at Birmingham, Drexel University, RTI International
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Mar 2010 (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.
The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.
Detailed description
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages. Participants from four sites in the Global Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; as necessary the food intervention and messages will be delivered at home by the assigned community coordinator or alternate. Outcome measures, obtained by a separate group of local, trained assessment workers, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Lyophilized meatDaily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) |
| 2 | Active comparator | Other: CerealDaily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months. |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year < -2) of at least 20% in young children.
Key exclusion criteria (5 listed)
- Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods.
- Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:
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 |
|---|---|---|
| Lyophilized meatDaily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) | Other | 1 |
| CerealDaily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months. | Other | 2 |
Primary outcome
Linear growth velocity
Time frame: 6 to 18 months of age
3 secondary outcomes
Infant Zinc and Ferritin levels
Time frame: 18 months
Bayleys II
Time frame: 18 months
Incidence of diarrhea, lower respiratory infection, and malaria
Time frame: 6 to 18 months
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 25 Nov 2013.
- Derived from this study: PubMed 37221030Manasyan A, Salas AA, Nolen T, Chomba E, Mazariegos M, Tshefu Kitoto A, Saleem S, Naqvi F, Hambidge KM, Goco N, McClure EM, Wallander JL, Biasini FJ, Goldenberg RL, Bose CL, Koso-Thomas M, Krebs NF, Carlo WA. Diagnostic accuracy of ASQ for screening of neurodevelopmental delays in low resource countries. BMJ Open. 2023 May 23;13(5):e065076. doi: 10.1136/bmjopen-2022-065076.
- Derived from this study: PubMed 22952176Krebs NF, Mazariegos M, Chomba E, Sami N, Pasha O, Tshefu A, Carlo WA, Goldenberg RL, Bose CL, Wright LL, Koso-Thomas M, Goco N, Kindem M, McClure EM, Westcott J, Garces A, Lokangaka A, Manasyan A, Imenda E, Hartwell TD, Hambidge KM. Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings. Am J Clin Nutr. 2012 Oct;96(4):840-7. doi: 10.3945/ajcn.112.041962. Epub 2012 Sep 5.
- Derived from this study: PubMed 21232139Krebs NF, Hambidge KM, Mazariegos M, Westcott J, Goco N, Wright LL, Koso-Thomas M, Tshefu A, Bose C, Pasha O, Goldenberg R, Chomba E, Carlo W, Kindem M, Das A, Hartwell T, McClure E; Complementary Feeding Study Group. Complementary feeding: a Global Network cluster randomized controlled trial. BMC Pediatr. 2011 Jan 13;11:4. doi: 10.1186/1471-2431-11-4.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lyophilized meat and Cereal in people with Complementary Feeding and Infant Growth, run by NICHD Global Network for Women's and Children's Health at 4 sites in 4 countries.
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 3 inclusion and 5 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Guatemala, Pakistan, Republic of the Congo, Zambia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Linear growth velocity (time frame: 6 to 18 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084109, which also lists 3 linked publications.
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 25 Nov 2013.