The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

The Washington University

Status: Completed

Conditions: Stunting; Environmental Enteric Dysfunction

Treatments: Dietary Supplement: Control; Dietary Supplement: multiple micronutrient; Dietary Supplement: BC/ egg

Study type: Interventional

Funder types: Other

Identifiers

NCT03801317

201808199

Details and patient eligibility

About

The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine colostrum or a control flour along with a multiple micronutrient powder to the diets of healthy Malawian children 9 months of age. This supplement provides additional essential amino acids, choline and immunoactive colostrum. Children will be receive either the supplement or control for 12 weeks. Children will have regular follow-up where anthropometry is measured. At enrollment and after 12 weeks, stool will be collected and a urinary lactulose permeability test conducted. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.

Enrollment: 278 patients

Sex: All

Ages: 9 to 10 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Children at 9-10 months of age

Exclusion criteria

• Malnutrition
• congenital abnormalities
• chronic diseases such as heart disease, cerebral palsy, or HIV infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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278 participants in 2 patient groups, including a placebo group

BC/ egg

Experimental group

Description:

4.3 grams egg powder + 5.7 grams bovine colostrum

Treatment:

Dietary Supplement: multiple micronutrient

Dietary Supplement: BC/ egg

Control

Placebo Comparator group

Description:

15 grams corn-soya blend

Treatment:

Dietary Supplement: multiple micronutrient

Dietary Supplement: Control