Infant GrowthNCT03993860
Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth
A study testing Fish Powder and Sorghum powder in people with Infant Growth, run by Mukuba University at 1 site in Zambia.
Trial summary
The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth
- What is being tested?
- Fish Powder and Sorghum powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteZambia
- Study dates
- 4 Apr 2019to 10 Jan 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 6 months attending under-five clinic at the sampled RHC. Infants should ideally be 6 months of age however, the study will provide leeway of 2 weeks, and therefore infants falling within the age range 5.5 - 6.5 months may be included. If a 5.5-month-old infant has however not been started with complementary food, the mother will be advised to only start at the age of 6 months with the product.
- Infants whose mothers give written consent
- Infants whose mothers have no plans of moving away during the study period
Who cannot join
- Infants with, chronic or congenital diseases/disorders that may affect the growth of the children. These may include Down syndrome, cerebral palsy, spina bifida and any other related condition.
- Premature infants
- infected infants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth in Samfya District, Luapula Province, Zambia
The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes.
Read the detailed description
Stunting is an irreversible consequence of inadequate growth during the early life of a child in the absence of appropriate interventions before the age of 2 years. Stunting affect 151 million (22.2%) of children worldwide. World Health Organisation (WHO) global nutrition target for 2025 is to reduce the number of stunted children under-five years by 40%.3,4 The first 1000 days (conception to 2years) is crucial for later development. It is also the period when stunting prevalence is at its highest. In Zambia, the stunting prevalence is 40%8 , 43% in Luapula province with Samfya district statistics as high as 49%.
Good complementary feeding of children contributes to the positive characteristics of growth trends observed in developed countries. It is a period of introducing solids and age of accelerated growth. Improved linear growth in food insecure homes is achievable by using locally available foods that are sustainable and usually acceptable. The role of fish's contribution to child's optimal growth and development in the first 1 000 days in Zambia has been reviewed. A food consumption survey also shows that fish is one of the highly consumed protein foods in low-income households in Zambia.To the investigators knowledge, fish has not been assessed as an early complementary food for infants aged 6 months in Zambia. This study will investigate the effect of providing dry fish powder to 6 months old infants (over a 6 months period) on their linear growth Research Question Can the introduction of fish during early complementary feeding improve infant linear growth in Samfya district, Zambia? Study Aim The aim of this study is to determine if the introduction of fish during early complementary feeding improves infant's linear growth outcomes.
Objectives Primary Objective The primary objective of the study is to evaluate the effect of introducing fish during early complementary feeding on growth outcomes of infants in Samfya district, Zambia.
Secondary Objectives
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine basic and underlying (socio-demographic, infants/maternal history) factors associated with stunting, wasting and underweight in the study area
- To determine the prevalence of fish allergy in the study area
- To assess the acceptability of fish powder as an early complementary food.
Methodology
Samfya district is a rural area in North-East Zambia in Luapula Province and has 210, 251 inhabitants, of which 42, 050 (20%) are under-five children. The study will be conducted at Shikamushile Rural Health Centre (RHC) in Samfya district. Shikamushi RHC is one of the 10 RHCs without any nutrition programme. It serves a population of 11, 800; 2400 (20%) of these children attend the under-five clinic at the centre. This centre has more cases of malnourished children referred to the hospital for treatment than any other RHC.
The study will be a single blinded randomised controlled trial. The trial will have two arms with the intervention group receiving fish powder (Chisense) while the control will be given a placebo in the form of sorghum powder. Infants aged 6 months will be followed up for a period of 6 months until they are 12 months old. The total sample size estimate is 238 infants, 119 infants per group with the possible attrition rate of 20%, and power of 80% to detect a 0.45 growth difference in length-for-age Z score between the intervention and control group.
The investigator intends to use a questionnaire to collect socio-demographic data and take anthropometric measurements (from both mothers and infants) at baseline to determine basic and underlying factors associated with stunting, wasting and underweight in the study area. The data set will include, mother's age, nutrition status, number of births, source of drinking water, family size, source of income, breastfeeding and complementary food. Anthropometric measurements will be used to determine the prevalence of stunting, wasting and underweight in the study area. In addition, a 24-hour dietary recall questionnaire will be administered to determine the type of food given to children. Furthermore, a skin prick test will be conducted at baseline on infants aged 6 months to determine the prevalence of fish allergy in the study area.
Infants will then be followed up for 6 months during which, infants in the intervention group will receive 12g (7.6g protein) fish powder while the control will receive 7g (0.9g protein) sorghum powder per day. The follow-up will include, weekly and monthly follow-up Weekly home visits: During weekly home visits, the research assistants will distribute pre-packed fish/sorghum powder to last a week to the intervention and control group respectively. Research assistants will keep record of any morbidities experienced by the infants. Adherence to the intervention will be assessed by reports from mothers of infants and empty fish powder storage bowls.
Monthly RHC visits: Each month the mothers in both the intervention and control group will have their infant's anthropometric (weight, length, head circumference and mid-upper aim circumference) measurements taken during visits at the RHC. A 24-hour dietary recall will be administered every two months to determine dietary intake of infants. After the intervention, mothers of infants will be given a questionnaire to assess acceptability of fish as an early complementary food. The questionnaire will have questions on the flavour, colour, and consumption.
Statistical Analysis: Descriptive statistics will be used to describe the incidence of allergy among the study infants. The relationships between continuous response variables and nominal input variables, for example different diets, will be analysed using appropriate ANOVA or pooled or Welch t-tests if the two groups are involved. Appropriate repeated measures ANOVA will be used when responses are measured at specific time intervals. When only two times are compared, this will be done with paired t-tests. The relation between nominal variables will be investigated with contingency tables and appropriate chi-square tests, such as the likelihood ratio chi-square test. A p-value of p < 0.05 will represent statistical significance and 95% confidence intervals will be used to describe the estimation of unknown parameters.
The study protocol has approval from the Health Research Ethics Committee (HREC) and Tropical Disease Research Centre (TDRC), Ndola Zambia. . Permission to conduct the study at Sikamushile rural health center was sought from Samfya District Medical Office (SDMO). The following was ensured, informed consents, freedom of participation/withdrawal, and anonymity.
- Conditions
- Infant Growth
- Being tested
- Fish Powder, Sorghum powder
- Keywords
- Infants, Growth, Stunting, Fish, Intervention
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish PowderDietary supplement
Dry small fish (Chisense) is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.
Sorghum powderDietary supplement
Dry sorghum is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Infants will be given fish powder called Chisense (Potamothrissa acutirostris) for a period of 6 months from the time they are 6 months up to the time they are 12 months. Receives: Dietary Supplement: Fish Powder |
| Control arm | Placebo comparator | Infants will be given fish powder called sorghum powder for a period of 6 months from the time they are 6 months up to the time they are 12 months. Receives: Dietary Supplement: Sorghum powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth
Mean change from baseline in length-for-age Z-scores at 7, 8, 9,10,11 and 12 months old.:WHO 2006 Growth Standards
Measured: At baseline (6 months), 7,8,9,10,11 and 12 months.
Secondary outcomes (5)
The percentage (%) of infants who will be stunted.
Mean length-for-age Z-scores at baseline (6 months), 7, 8, 9,10,11 and 12 months : WHO 2006 Growth Standards
Measured: At baseline (6 months) 7, 8, 9,10,11 and 12 months
The percentages (%) of infants who will be underweight and wasted in the study.
Mean Weight-for-length/Weight-for_age at baseline (6 months) for-age WHO 2006 growth Standards.
Measured: At baseline (6 months) 7, 8, 9,10,11 and 12 months
The percentage (%) of infants who will be allergic to fish .
A skin prick test using fish (chisense) extract. Histamine dihydrochloride 10 mg/ml as a positive and water as a negative control. A skin reaction of more than 3mm will be considered positive.
Measured: 6 months
Acceptability of fish powder as an early complementary food:
Mothers of infants in the intervention group will be interviewed on the acceptability of fish as an early complementary food using a questionnaire. Taste, smell, colour, flavour, amount consumed by the infant (grams per day). Fours (4) scores out of five (5) will be considered acceptable.
Measured: At end-line of the study (when infants are 12 months old)
Factors associated with stunting, wasting and underweight in the study area.
The socio-demographic data ( for example; age of the mother, level of education, occupation, family size, source of income and marital status) will be compared with the results of the infant's anthropometric measurements. Linear regression mixed effect regression modal will be used to assess the interventions effect on growth (LAZ, WAZ, and WLZ)
Measured: After collecting baseline information (When infants are 6 months old)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start4 Apr 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies 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
- Model description
- An independent statistician not be part of the study prepared the randomisation schedule. All eligible infants were randomly assigned to either the intervention (Chisense fish powder) or the control (placebo in the form of sorghum powder) group at 6 months. A 1:1 ratio using a computerised random number generator and block randomisation in Microsoft Excel was used to randomise the infants to two groups of equal size. The schedule was stratified by the gender of infants (boy or girl) to enable gender balance in both groups. Allocation of concealment was done using a central randomisation service through a computer algorithm to protect the randomisation schedule. If there two infants from the same household or in case of twins, they were treated as a single baby during randomisation to avoid contamination. However, each child had his or her own code and will be assessed as an individual throughout the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mukuba University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, Medical Research Council, South Africa
- Responsible party
- Principal investigator, Given Chipili, Mukuba University
- Investigators
- Given Chipili, Principal investigator, Mukuba University, Kitwe, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993860
- Sponsor's protocol ID
- STC/2019/03
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is part of my PhD. The information will be shared on the Stellenbosch University website two years after graduation.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth in Samfya District, Luapula Province, Zambia
- ClinicalTrials.gov ID
- NCT03993860
- Acronym / sponsor ID
- STC/2019/03
- Conditions
- Infant Growth
- Keywords
- Infants, Growth, Stunting, Fish, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Mukuba UniversityUniversity, hospital or other
- Collaborators
- University of Stellenbosch, Medical Research Council, South Africa
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 21 Jun 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.
The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes.
Detailed description
Stunting is an irreversible consequence of inadequate growth during the early life of a child in the absence of appropriate interventions before the age of 2 years. Stunting affect 151 million (22.2%) of children worldwide. World Health Organisation (WHO) global nutrition target for 2025 is to reduce the number of stunted children under-five years by 40%.3,4 The first 1000 days (conception to 2years) is crucial for later development. It is also the period when stunting prevalence is at its highest. In Zambia, the stunting prevalence is 40%8 , 43% in Luapula province with Samfya district statistics as high as 49%.
Good complementary feeding of children contributes to the positive characteristics of growth trends observed in developed countries. It is a period of introducing solids and age of accelerated growth. Improved linear growth in food insecure homes is achievable by using locally available foods that are sustainable and usually acceptable. The role of fish's contribution to child's optimal growth and development in the first 1 000 days in Zambia has been reviewed. A food consumption survey also shows that fish is one of the highly consumed protein foods in low-income households in Zambia.To the investigators knowledge, fish has not been assessed as an early complementary food for infants aged 6 months in Zambia. This study will investigate the effect of providing dry fish powder to 6 months old infants (over a 6 months period) on their linear growth Research Question Can the introduction of fish during early complementary feeding improve infant linear growth in Samfya district, Zambia? Study Aim The aim of this study is to determine if the introduction of fish during early complementary feeding improves infant's linear growth outcomes.
Objectives Primary Objective The primary objective of the study is to evaluate the effect of introducing fish during early complementary feeding on growth outcomes of infants in Samfya district, Zambia.
Secondary Objectives
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine the prevalence of stunting in 6-months old children in the study area.
- To determine basic and underlying (socio-demographic, infants/maternal history) factors associated with stunting, wasting and underweight in the study area
- To determine the prevalence of fish allergy in the study area
- To assess the acceptability of fish powder as an early complementary food.
Methodology
Samfya district is a rural area in North-East Zambia in Luapula Province and has 210, 251 inhabitants, of which 42, 050 (20%) are under-five children. The study will be conducted at Shikamushile Rural Health Centre (RHC) in Samfya district. Shikamushi RHC is one of the 10 RHCs without any nutrition programme. It serves a population of 11, 800; 2400 (20%) of these children attend the under-five clinic at the centre. This centre has more cases of malnourished children referred to the hospital for treatment than any other RHC.
The study will be a single blinded randomised controlled trial. The trial will have two arms with the intervention group receiving fish powder (Chisense) while the control will be given a placebo in the form of sorghum powder. Infants aged 6 months will be followed up for a period of 6 months until they are 12 months old. The total sample size estimate is 238 infants, 119 infants per group with the possible attrition rate of 20%, and power of 80% to detect a 0.45 growth difference in length-for-age Z score between the intervention and control group.
The investigator intends to use a questionnaire to collect socio-demographic data and take anthropometric measurements (from both mothers and infants) at baseline to determine basic and underlying factors associated with stunting, wasting and underweight in the study area. The data set will include, mother's age, nutrition status, number of births, source of drinking water, family size, source of income, breastfeeding and complementary food. Anthropometric measurements will be used to determine the prevalence of stunting, wasting and underweight in the study area. In addition, a 24-hour dietary recall questionnaire will be administered to determine the type of food given to children. Furthermore, a skin prick test will be conducted at baseline on infants aged 6 months to determine the prevalence of fish allergy in the study area.
Infants will then be followed up for 6 months during which, infants in the intervention group will receive 12g (7.6g protein) fish powder while the control will receive 7g (0.9g protein) sorghum powder per day. The follow-up will include, weekly and monthly follow-up Weekly home visits: During weekly home visits, the research assistants will distribute pre-packed fish/sorghum powder to last a week to the intervention and control group respectively. Research assistants will keep record of any morbidities experienced by the infants. Adherence to the intervention will be assessed by reports from mothers of infants and empty fish powder storage bowls.
Monthly RHC visits: Each month the mothers in both the intervention and control group will have their infant's anthropometric (weight, length, head circumference and mid-upper aim circumference) measurements taken during visits at the RHC. A 24-hour dietary recall will be administered every two months to determine dietary intake of infants. After the intervention, mothers of infants will be given a questionnaire to assess acceptability of fish as an early complementary food. The questionnaire will have questions on the flavour, colour, and consumption.
Statistical Analysis: Descriptive statistics will be used to describe the incidence of allergy among the study infants. The relationships between continuous response variables and nominal input variables, for example different diets, will be analysed using appropriate ANOVA or pooled or Welch t-tests if the two groups are involved. Appropriate repeated measures ANOVA will be used when responses are measured at specific time intervals. When only two times are compared, this will be done with paired t-tests. The relation between nominal variables will be investigated with contingency tables and appropriate chi-square tests, such as the likelihood ratio chi-square test. A p-value of p < 0.05 will represent statistical significance and 95% confidence intervals will be used to describe the estimation of unknown parameters.
The study protocol has approval from the Health Research Ethics Committee (HREC) and Tropical Disease Research Centre (TDRC), Ndola Zambia. . Permission to conduct the study at Sikamushile rural health center was sought from Samfya District Medical Office (SDMO). The following was ensured, informed consents, freedom of participation/withdrawal, and anonymity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- An independent statistician not be part of the study prepared the randomisation schedule. All eligible infants were randomly assigned to either the intervention (Chisense fish powder) or the control (placebo in the form of sorghum powder) group at 6 months. A 1:1 ratio using a computerised random number generator and block randomisation in Microsoft Excel was used to randomise the infants to two groups of equal size. The schedule was stratified by the gender of infants (boy or girl) to enable gender balance in both groups. Allocation of concealment was done using a central randomisation service through a computer algorithm to protect the randomisation schedule. If there two infants from the same household or in case of twins, they were treated as a single baby during randomisation to avoid contamination. However, each child had his or her own code and will be assessed as an individual throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: Fish PowderInfants will be given fish powder called Chisense (Potamothrissa acutirostris) for a period of 6 months from the time they are 6 months up to the time they are 12 months. |
| Control arm | Placebo comparator | Dietary Supplement: Sorghum powderInfants will be given fish powder called sorghum powder for a period of 6 months from the time they are 6 months up to the time they are 12 months. |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 6 months attending under-five clinic at the sampled RHC. Infants should ideally be 6 months of age however, the study will provide leeway of 2 weeks, and therefore infants falling within the age range 5.5 - 6.5 months may be included. If a 5.5-month-old infant has however not been started with complementary food, the mother will be advised to only start at the age of 6 months with the product.
- Infants whose mothers give written consent
- Infants whose mothers have no plans of moving away during the study period
Key exclusion criteria (3 listed)
- Infants with, chronic or congenital diseases/disorders that may affect the growth of the children. These may include Down syndrome, cerebral palsy, spina bifida and any other related condition.
- Premature infants
- infected infants
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 |
|---|---|---|
| Fish PowderDry small fish (Chisense) is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth. | Dietary supplement | Intervention arm |
| Sorghum powderDry sorghum is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth. | Dietary supplement | Control arm |
Primary outcome
Linear growth
Time frame: At baseline (6 months), 7,8,9,10,11 and 12 months.
Mean change from baseline in length-for-age Z-scores at 7, 8, 9,10,11 and 12 months old.:WHO 2006 Growth Standards
5 secondary outcomes
The percentage (%) of infants who will be stunted.
Time frame: At baseline (6 months) 7, 8, 9,10,11 and 12 months
The percentages (%) of infants who will be underweight and wasted in the study.
Time frame: At baseline (6 months) 7, 8, 9,10,11 and 12 months
The percentage (%) of infants who will be allergic to fish .
Time frame: 6 months
Acceptability of fish powder as an early complementary food:
Time frame: At end-line of the study (when infants are 12 months old)
Factors associated with stunting, wasting and underweight in the study area.
Time frame: After collecting baseline information (When infants are 6 months old)
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 22 Jan 2020.
- Individual participant dataSharing planned: Yes. This study is part of my PhD. The information will be shared on the Stellenbosch University website two years after graduation.
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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.
Given Chipili principal investigator
Mukuba University, Kitwe, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Powder and Sorghum powder in people with Infant Growth, run by Mukuba University at 1 site in Zambia.
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 3 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 22 Jan 2020. 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 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. Some participants in this study may receive a placebo. 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?
Linear growth (time frame: At baseline (6 months), 7,8,9,10,11 and 12 months.). 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 22 Jan 2020.