Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth

NCT03993860 | Completed

• 1 other identifier: STC/2019/03
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to provide proof that giving fish during early complementary feeding improves infant linear growth outcomes.

Conditions

Infant Growth

Keywords

Infants; Growth; Stunting; Fish; Intervention

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline (6 months), 7,8,9,10,11 and 12 months.

Secondary Outcomes (5)

• The percentage (%) of infants who will be stunted.

  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.

  At baseline (6 months) 7, 8, 9,10,11 and 12 months

• The percentage (%) of infants who will be allergic to fish .

  6 months

• Acceptability of fish powder as an early complementary food:

  At end-line of the study (when infants are 12 months old)

• Factors associated with stunting, wasting and underweight in the study area.

  After collecting baseline information (When infants are 6 months old)

Study Arms (2)

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.

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.

Dietary Supplement: Sorghum powder

Interventions

Fish Powder DIETARY_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.

Intervention arm

Sorghum powder DIETARY_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.

Control arm

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mukuba University: lead
• University of Stellenbosch: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (1)

Shikamushile Rural Health Centre

Samfya, Luapula Province, 01010, Zambia

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Given Chipili

  Mukuba University, Kitwe, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: During grinding of sorghum powder, roasted small fish (3g/100g of sorghum) was added to the sorghum to provide a similar fish aroma as the fish product. The fish powder (12g)/ sorghum powder (12g) was then pre-packed in small plastic sachets. The participant and the field workers (research assistants and health workers) are blinded while the principal investigator (PI) is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 21, 2019
• Study Start: April 4, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years
• Access Criteria: Through the Stellenbosch University official website

Locations

ZA (1)