Child Health, Agriculture and Integrated Nutrition

NCT04874688 | Completed

• 1 other identifier: MRCZ/A/2679
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

CHAIN is an open-label, individually randomized trial of improved infant and young child feeding (IYCF) versus "IYCF-plus" among 192 infants enrolled between 5-6 months of age in Shurugwi district, rural Zimbabwe. Interventions comprise sequential behaviour-change interventions delivered by village health workers together with food supplements. In the IYCF arm, infants will receive white maize and small-quantity lipid-based nutrient supplement (SQ-LNS) daily from 6 months of age. In the IYCF-plus arm, infants will receive orange pro-vitamin A-biofortified maize, and SQ-LNS, plus powdered sugar beans, moringa and whole egg powder. The primary outcome will be the proportion of infants in each trial arm reaching daily energy requirements at 9 months of age (visit window 9-11 months of age). Secondary outcomes are other nutrient intake, anthropometry and haemoglobin. Tertiary outcomes are laboratory measures of microbiome composition, environmental enteric dysfunction, inflammation, innate immune function, circulating choline and essential amino acids, and urinary metabolic profile. Two qualitative substudies will explore i) the feasibility and acceptability of the IYCF-plus intervention; and ii) the influence of migration on household food consumption and production.

Conditions

Stunting

Keywords

Infant and young child feeding; Nutrients; Environmental enteric dysfunction; Microbiota; Immune function; Systemic inflammation; Metabolic profile

Outcome Measures

Primary Outcomes (1)

• Energy intake

  Percentage of infants meeting daily energy requirements, measured by multi-pass 24-hour dietary recall,

  9 months of age (window 9-11 months)

Secondary Outcomes (8)

• Protein intake

  9 months of age (window 9-11 months)

• Iron intake

  9 months of age (window 9-11 months)

• Zinc intake

  9 months of age (window 9-11 months)

• Folate intake

  9 months of age (window 9-11 months)

• Height-for-age Z-score

  9 months of age (window 9-11 months)

Other Outcomes (7)

• Microbiome maturity

  9 months of age (window 9-11 months)

• Environmental enteric dysfunction

  9 months of age (window 9-11 months)

• Innate immune cell phenotype

  9 months of age (window 9-11 months)

Study Arms (2)

IYCF-Only

ACTIVE COMPARATOR

Infants in the IYCF-only arm will receive white maize and SQ-LNS daily from 6 months of age, and the primary caregiver will receive a series of behaviour-change modules delivered by village health workers.

Dietary Supplement: Small-quantity lipid-based nutrient supplement; Dietary Supplement: White maize meal

IYCF-Plus

EXPERIMENTAL

Infants in the IYCF-plus arm will receive orange provitamin A-fortified maize and SQ-LNS daily from 6 months of age, plus powdered NUA-45 sugar beans, moringa leaf powder, and powdered whole egg; and the primary caregiver will receive a series of behaviour-change modules delivered by village health workers.

Dietary Supplement: Small-quantity lipid-based nutrient supplement; Dietary Supplement: Provitamin A biofortified maize; Dietary Supplement: NUA-45 biofortified sugar beans; Dietary Supplement: Moringa oleifera; Dietary Supplement: Whole egg powder

Interventions

NUA-45 biofortified sugar beans DIETARY_SUPPLEMENT

NUA 45 bean powder is ground from roasted iron and zinc-rich biofortified sugar beans. NUA 45 bean powder will be sourced from Sky Brands Ltd Company. Children will consume a daily dose of 5g - 15g of NUA 45 bean powder added to complementary foods.

IYCF-Plus

Whole egg powder DIETARY_SUPPLEMENT

Egg Powder is hydrolysed non-genetically modified organism (GMO), fine and unflavoured whole egg powder. It is processed with no additives, preservatives, lecithin, added sugar, soy or monosodium glutamate. Egg powder will be sourced from France (A \& D Food Ingredients - distributor in South Africa). Children in the IYCF-plus arm will receive a daily dose of 14g egg powder. A 15% extra amount of egg powder will be provided to families taking into consideration of household sharing. Egg powder will be provided in sealed plastic jars similar to that of peanut butter and households will receive promotion messages to store the powder in a cool, dry place and avoiding contact with water or moisture during use.

IYCF-Plus

White maize meal DIETARY_SUPPLEMENT

Commercial white maize meal will be provided monthly. Infants age 6-8 months will receive 45g (3 tablespoons) daily; infants aged 9-12 months will receive 71g (4.5 tablespoons) daily.

IYCF-Only

Small-quantity lipid-based nutrient supplement DIETARY_SUPPLEMENT

Small Quantity Lipid-based Nutrient Supplement (SQ-LNS) is a food supplement rich in both macro and micronutrients (calories, proteins, fat and multivitamin mix). SQ-LNS is not considered a regulated drug product in Zimbabwe, or by the United States Food and Drug Administration (FDA). It is commercially available for prevention of chronic malnutrition, produced by Nutriset (https://www.nutriset.fr/products/en/enov-nutributter2). Each child will receive a daily sachet of 20g SQ-LNS between 6-12 months of age, consumed directly from the sachet or mixed with porridge.

IYCF-Only; IYCF-Plus

Provitamin A biofortified maize DIETARY_SUPPLEMENT

Provitamin A Maize Meal is orange maize-meal processed from provitamin A-rich orange maize. PVA maize meal will be sourced from International Maize and Wheat Improvement Centre (CIMMYT). Children in the intervention arm will consume 13g - 128g of pro-vitamin A (PVA) maize meal, with added powders. Each family will receive a monthly ration of 5kg PVA maize and this ration takes into consideration of household sharing. Families with children in the IYCF arm will receive white maize meal.

Also known as: Orange maize

IYCF-Plus

Moringa oleifera DIETARY_SUPPLEMENT

Moringa oleifera is an edible plant abundant in dry tropic regions including Zimbabwe. It is known to be rich in micronutrients and has been widely used in Zimbabwe and around the world both as a food and a herb. Moringa oleifera leaf powder, is a dried and ground powder produced from Moringa oleifera leaves using traditional methods. It has been widely used to fortify complementary foods in the African region with the aim of improving micronutrient status. Moringa oleifera leaf powder will be sourced from Lemex Products Company. Children will receive a daily dose of 5g - 15g of Moringa leaf powder added to complementary foods.

Also known as: Moringa leaf powder

IYCF-Plus

Eligibility Criteria

• Age: 5 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 5-6 months
• Planning to live in the study area for the duration of the trial

You may not qualify if:

• Severe infant disability that interferes with feeding
• Known allergy to peanuts or eggs

Sponsors & Collaborators

• Queen Mary University of London: lead
• CIMMYT: collaborator
• University of Southampton: collaborator
• Ministry of Health and Child Welfare, Zimbabwe: collaborator

Study Sites (1)

Zvitambo Institute for Maternal and Child Health Research

Harare, Zimbabwe

Location

Related Publications (1)

• Smith LE, Chagwena DT, Bourke C, Robertson R, Fernando S, Tavengwa NV, Cairns J, Ndhlela T, Matumbu E, Brown T, Datta K, Mutasa B, Tengende A, Chidhanguro D, Langhaug L, Makanza M, Chasekwa B, Mutasa K, Swann J, Kelly P, Ntozini R, Prendergast A. Child Health, Agriculture and Integrated Nutrition (CHAIN): protocol for a randomised controlled trial of improved infant and young child feeding in rural Zimbabwe. BMJ Open. 2022 Dec 30;12(12):e056435. doi: 10.1136/bmjopen-2021-056435.

  PMID: 36585147 DERIVED

Related Links

• Study protocol, intervention materials, statistical analysis plan and CRFs will be posted on this Open Science Framework site

MeSH Terms

Conditions

Growth Disorders

Interventions

flocculant protein MO 2.1, Moringa oleifera

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura E Smith, PhD

  Zvitambo Institute for Maternal and Child Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Families and fieldworkers measuring outcome measures are not blinded. Analysts and laboratory scientists will be blinded to intervention arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individually randomized, unblinded clinical trial

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 6, 2021
• Study Start: April 26, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after primary analysis is completed

Locations

ZI (1)