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Completed

NCT Number: NCT07794085

Growth and Nutritional Impact of Small Fish Powder Supplementation in Infants

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.

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Key information

Age range

6 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Garoua 1 Health District

Garoua, Cameroon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Small Fish Powder

Dietary 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 Flour

Dietary 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight-for-Height Z-score

    Time frame: 6 months

    Prevention of acute malnutrition, defined as weight-for-height Z-score ≥ -1.5 SD.

  2. Weight Gain

    Time frame: 6 months

    Mean change in body weight (kg) from baseline to six months.

  3. Mid-Upper Arm Circumference (MUAC) Gain

    Time frame: 6 months

    Mean change in MUAC (cm) from baseline to six months.

  4. 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.

  5. 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.

Other outcomes

  1. Hemoglobin Concentration

    Time frame: 6 months

    Mean change in hemoglobin levels (g/dL) from baseline to six months.

  2. Malaria Prevalence

    Time frame: 6 months

    Proportion of children testing positive for malaria by rapid diagnostic test (RDT) during follow-up.

Sponsors and collaborators

Lead sponsor

Centre for Food and Nutrition Research, Yaounde

Other Gov

Collaborators

  • Ministry of Public Health, Cameroon
  • UNICEF

Registry information

Official study title

Assessing the Efficacy of Small Fish Powder Supplementation on the Growth of Infants Aged 6-7 Months in Northern Cameroon

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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