- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07794085
Growth and Nutritional Impact of Small Fish Powder Supplementation in Infants
Assessing the Efficacy of Small Fish Powder Supplementation on the Growth of Infants Aged 6-7 Months in Northern Cameroon
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Garoua, Cameroon
- Garoua 1 Health District
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe anemia.
- Severe acute malnutrition.
- Clinically defined illness such as dehydration, severe diarrhea, or respiratory disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Small Fish Powder
|
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.
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.
|
|
Active Comparator: Millet Flour
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight-for-Height Z-score
Time Frame: 6 months
|
Prevention of acute malnutrition, defined as weight-for-height Z-score ≥ -1.5 SD.
|
6 months
|
|
Weight Gain
Time Frame: 6 months
|
Mean change in body weight (kg) from baseline to six months.
|
6 months
|
|
Mid-Upper Arm Circumference (MUAC) Gain
Time Frame: 6 months
|
Mean change in MUAC (cm) from baseline to six months.
|
6 months
|
|
Morbidity Frequency
Time Frame: 6 months
|
Number of morbidity episodes (e.g., diarrhea, respiratory infections, malaria) recorded per child during the six-month intervention period.
|
6 months
|
|
Intervention Failure Rate
Time Frame: 6 months
|
Proportion of children failing to achieve growth effectiveness (height-for-age Z-score < -1.5 SD) after six months.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin Concentration
Time Frame: 6 months
|
Mean change in hemoglobin levels (g/dL) from baseline to six months.
|
6 months
|
|
Malaria Prevalence
Time Frame: 6 months
|
Proportion of children testing positive for malaria by rapid diagnostic test (RDT) during follow-up.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRASAN-UNICEF2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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