Child MalnutritionNCT07794085
Growth and Nutritional Impact of Small Fish Powder Supplementation in Infants
A study testing Small Fish Powder and Millet Flour in people with Child Malnutrition, run by Centre for Food and Nutrition Research, Yaounde at 1 site in Cameroon.
Trial summary
This randomized controlled trial evaluated the effectiveness of supplementing the diets of infants aged 6-7 months with small fish powder on growth outcomes in the Garoua 1st Health District, Northern Cameroon. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Small Fish Powder and Millet Flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Jul 2024to 1 Feb 2025
- 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 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 6-7 months.
- Families residing in the study area with no plans to relocate during the study period.
- Absence of severe illness at enrollment.
Who cannot join
- Severe anemia.
- Severe acute malnutrition.
- Clinically defined illness such as dehydration, severe diarrhea, or respiratory disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of Small Fish Powder Supplementation on the Growth of Infants Aged 6-7 Months in Northern Cameroon
This randomized controlled trial evaluated the effectiveness of supplementing the diets of infants aged 6-7 months with small fish powder on growth outcomes in the Garoua 1st Health District, Northern Cameroon. A total of 240 infants were enrolled and randomly assigned to receive either small fish powder or a millet flour control for six months. The primary endpoint was growth effectiveness, defined as achieving a height-for-age Z-score ≥ -1.5 after six months. Secondary outcomes included prevention of acute malnutrition, weight gain, mid-upper arm circumference (MUAC) gain, morbidity frequency, and intervention failure rate. Study procedures comprised weekly ration distribution, anthropometric measurements, hemoglobin and malaria testing, and parental nutritional education. Data were analyzed using SPSS and XLSTAT, with statistical significance set at p < 0.05.
- Conditions
- Child Malnutrition
- Being tested
- Small Fish Powder, Millet Flour
- Keywords
- Small fish powder, Complementary feeding, Infant malnutrition, Nutritional effectiveness, Northern Cameroon
- Medical subject headings
- Child Nutrition Disorders, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Fish PowderDietary supplement
Infants aged 6-7 months will receive a daily ration of small fish powder equivalent to ~25 kcal/day, providing approximately 65% of the recommended daily protein intake for children aged 6-24 months. Parents will be instructed on how to incorporate the powder into the child's usual diet. Weekly distribution will occur at the health center, accompanied by monthly nutrition education and biweekly clinical monitoring.
Millet FlourDietary supplement
Infants aged 6-7 months will receive a daily ration of millet flour equivalent to ~25 kcal/day, providing approximately 10% of the recommended daily protein intake for children aged 6-24 months. To standardize taste, 3% fish powder will be added. Parents will be instructed on how to incorporate the flour into the child's usual diet. Weekly distribution will occur at the health center, accompanied by monthly nutrition education and biweekly clinical monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Small Fish Powder | Experimental | Not described Receives: Dietary Supplement: Small Fish Powder; Dietary Supplement: Millet Flour |
| Millet Flour | Active comparator | Not described Receives: Dietary Supplement: Small Fish Powder; Dietary Supplement: Millet Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height-for-Age Z-score
Growth effectiveness, defined as the proportion of children achieving a height-for-age Z-score ≥ -1.5 SD after six months of supplementation.
Measured: 6 months
Secondary outcomes (5)
Weight-for-Height Z-score
Prevention of acute malnutrition, defined as weight-for-height Z-score ≥ -1.5 SD.
Measured: 6 months
Weight Gain
Mean change in body weight (kg) from baseline to six months.
Measured: 6 months
Mid-Upper Arm Circumference (MUAC) Gain
Mean change in MUAC (cm) from baseline to six months.
Measured: 6 months
Morbidity Frequency
Number of morbidity episodes (e.g., diarrhea, respiratory infections, malaria) recorded per child during the six-month intervention period.
Measured: 6 months
Intervention Failure Rate
Proportion of children failing to achieve growth effectiveness (height-for-age Z-score < -1.5 SD) after six months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a comparative effectiveness trial evaluating infant growth from 6-7 months of age over a six month period. A randomized controlled parallel design will be used, with allocation to either small fish powder supplementation or a control prepared with millet flour. A randomization list will be generated using a random number generator (Stat Trek). Allocation will be determined by parents drawing coded numbers from an opaque bag, each corresponding to one of the products. The code will be accessible only to distribution staff. Clinical evaluators will remain blinded to group assignment. If two infants belong to the same household, they will receive the same product to minimize potential confusion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Food and Nutrition Research, Yaounde
- Sponsor type
- Other government
- Collaborators
- Ministry of Public Health, Cameroon, UNICEF
- Responsible party
- Principal investigator, Medoua Nama Gabriel, Centre for Food and Nutrition Research, Yaounde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794085
- Sponsor's protocol ID
- CRASAN-UNICEF2024
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline Characteristics: Infant age, sex, household sociodemographic data, maternal education, household food security and dietary diversity scores. Anthropometric Data: Weight, height/length, mid upper arm circumference (MUAC), Derived indices (height for age, weight for age, weight for height Z scores). Clinical and Laboratory Data: Hemoglobin concentration, Malaria test results, Morbidity episodes (diarrhea, respiratory infections, fever, malaria). Dietary Intake Data: 24 hour dietary recall, Weekly food frequency data, Product consumption records (amount of small fish powder or millet flour consumed, adherence, unused product returned). Follow up Data: Longitudinal measurements at enrollment, 2 months, 4 months, and 6 months, Survival analysis endpoints (growth recovery vs. non recovery).
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Small Fish Powder Supplementation on the Growth of Infants Aged 6-7 Months in Northern Cameroon
- ClinicalTrials.gov ID
- NCT07794085
- Acronym / sponsor ID
- CRASAN-UNICEF2024
- Conditions
- Child Malnutrition
- Keywords
- Small fish powder, Complementary feeding, Infant malnutrition, Nutritional effectiveness, Northern Cameroon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre for Food and Nutrition Research, YaoundeOther government
- Collaborators
- Ministry of Public Health, Cameroon, UNICEF
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 31 Aug 2026 (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 randomized controlled trial evaluated the effectiveness of supplementing the diets of infants aged 6-7 months with small fish powder on growth outcomes in the Garoua 1st Health District, Northern Cameroon. A total of 240 infants were enrolled and randomly assigned to receive either small fish powder or a millet flour control for six months. The primary endpoint was growth effectiveness, defined as achieving a height-for-age Z-score ≥ -1.5 after six months. Secondary outcomes included prevention of acute malnutrition, weight gain, mid-upper arm circumference (MUAC) gain, morbidity frequency, and intervention failure rate. Study procedures comprised weekly ration distribution, anthropometric measurements, hemoglobin and malaria testing, and parental nutritional education. Data were analyzed using SPSS and XLSTAT, with statistical significance set at p < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a comparative effectiveness trial evaluating infant growth from 6-7 months of age over a six month period. A randomized controlled parallel design will be used, with allocation to either small fish powder supplementation or a control prepared with millet flour. A randomization list will be generated using a random number generator (Stat Trek). Allocation will be determined by parents drawing coded numbers from an opaque bag, each corresponding to one of the products. The code will be accessible only to distribution staff. Clinical evaluators will remain blinded to group assignment. If two infants belong to the same household, they will receive the same product to minimize potential confusion.
| Arm | Type | Receives |
|---|---|---|
| Small Fish Powder | Experimental | Dietary Supplement: Small Fish Powder, Dietary Supplement: Millet Flour |
| Millet Flour | Active comparator | Dietary Supplement: Small Fish Powder, Dietary Supplement: Millet Flour |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 6-7 months.
- Families residing in the study area with no plans to relocate during the study period.
- Absence of severe illness at enrollment.
Key exclusion criteria (3 listed)
- Severe anemia.
- Severe acute malnutrition.
- Clinically defined illness such as dehydration, severe diarrhea, or respiratory disease.
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 |
|---|---|---|
| Small Fish PowderInfants aged 6-7 months will receive a daily ration of small fish powder equivalent to ~25 kcal/day, providing approximately 65% of the recommended daily protein intake for children aged 6-24 months. Parents will be instructed on how to incorporate the powder into the child's usual diet. Weekly distribution will occur at the health center, accompanied by monthly nutrition education and biweekly clinical monitoring. | Dietary supplement | Millet Flour, Small Fish Powder |
| Millet FlourInfants aged 6-7 months will receive a daily ration of millet flour equivalent to ~25 kcal/day, providing approximately 10% of the recommended daily protein intake for children aged 6-24 months. To standardize taste, 3% fish powder will be added. Parents will be instructed on how to incorporate the flour into the child's usual diet. Weekly distribution will occur at the health center, accompanied by monthly nutrition education and biweekly clinical monitoring. | Dietary supplement | Millet Flour, Small Fish Powder |
Primary outcome
Height-for-Age Z-score
Time frame: 6 months
Growth effectiveness, defined as the proportion of children achieving a height-for-age Z-score ≥ -1.5 SD after six months of supplementation.
5 secondary outcomes
Weight-for-Height Z-score
Time frame: 6 months
Weight Gain
Time frame: 6 months
Mid-Upper Arm Circumference (MUAC) Gain
Time frame: 6 months
Morbidity Frequency
Time frame: 6 months
Intervention Failure Rate
Time frame: 6 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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. Baseline Characteristics: Infant age, sex, household sociodemographic data, maternal education, household food security and dietary diversity scores. Anthropometric Data: Weight, height/length, mid upper arm circumference (MUAC), Derived indices (height for age, weight for age, weight for height Z scores). Clinical and Laboratory Data: Hemoglobin concentration, Malaria test results, Morbidity episodes (diarrhea, respiratory infections, fever, malaria). Dietary Intake Data: 24 hour dietary recall, Weekly food frequency data, Product consumption records (amount of small fish powder or millet flour consumed, adherence, unused product returned). Follow up Data: Longitudinal measurements at enrollment, 2 months, 4 months, and 6 months, Survival analysis endpoints (growth recovery vs. non recovery).
Related trials for Child Malnutrition
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruitingPhase 2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
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 Small Fish Powder and Millet Flour in people with Child Malnutrition, run by Centre for Food and Nutrition Research, Yaounde at 1 site in Cameroon.
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 31 Aug 2026. 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 Cameroon. 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: 6 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 31 Aug 2026.