Protein Plus: Improving Infant Growth Through Diet and Enteric Health (JiVitA-6)

Johns Hopkins Bloomberg School of Public Health logo

Johns Hopkins Bloomberg School of Public Health

Status and phase

Completed
Phase 3
Phase 2

Conditions

Malnutrition; Protein
Stunting
Campylobacter Infections
Enteric Pathogens

Treatments

Behavioral: Nutrition Education
Dietary Supplement: Protein Supplement
Drug: Azithromycin Oral Product
Dietary Supplement: Egg
Drug: Placebos
Dietary Supplement: Isocaloric Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT03683667
OPP1163259 (Other Grant/Funding Number)
00008000

Details and patient eligibility

About

This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

Full description

Stunting a major public health problem in Bangladesh, where 36% of children under the age of five are too short for their age. While dietary data indicate that protein intakes of infants and young children are largely in line with requirements, the extent to which requirements derived for healthy infants and young children are relevant in the context of frequent infections remains an important research question. Recent investigations indicate widespread pathogen carriage among Bangladeshi infants, with virtually all having at least one detectable pathogen in nondiarrheal stools by six months of age. Campylobacter and pathogenic E. Coli predominate in this setting. Enteric pathogens can compete with the host for available nutrients or alter nutrient metabolism. Acting via environmental enteric dysfunction, they can alter both digestion-through loss of digestive enzymes-and absorption of nutrients. Microbial translocation may further alter specific amino acid requirements. Even in the absence of acute diarrheal disease, enteric pathogen carriage is strongly associated with linear growth faltering. Combining the effects of high pathogen burden and poor diet, as indicated by low energy and protein from complementary foods, observational evidence suggests that the potentially preventable length-for-age Z-score deficit may be as high as 0.98. The present trial will test the combination of a) protein supplementation in the form of a protein-rich blended food or an egg, both fed daily to infants 6-12 months of age, and b) azithromycin treatment for enteric pathogens. The primary outcome will be change in length-for-age Z-score from the 6 to 12 months. Biochemical, microbiological and clinical intermediates will be measured to inform our secondary aims.

Enrollment

5,283 patients

Sex

All

Ages

3 to 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Born to women enrolled in ongoing community trial (NCT02909179) over a one-year period

Exclusion criteria

Born to women not registered as part of the ongoing community trial (NCT02909179)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

5,283 participants in 8 patient groups, including a placebo group

Placebo & Control
Placebo Comparator group
Description:
Placebo / Nutrition education
Treatment:
Drug: Placebos
Behavioral: Nutrition Education
Placebo & Protein Supplement
Experimental group
Description:
Placebo / Protein-rich blended food / Nutrition education
Treatment:
Drug: Placebos
Behavioral: Nutrition Education
Dietary Supplement: Protein Supplement
Placebo & Isocaloric Supplement
Placebo Comparator group
Description:
Placebo / Isocaloric blended food / Nutrition education
Treatment:
Dietary Supplement: Isocaloric Supplement
Drug: Placebos
Behavioral: Nutrition Education
Placebo & Egg
Experimental group
Description:
Placebo / Egg / Nutrition education
Treatment:
Drug: Placebos
Dietary Supplement: Egg
Behavioral: Nutrition Education
Azithromycin & Control
Experimental group
Description:
Azithromycin / Nutrition education
Treatment:
Drug: Azithromycin Oral Product
Behavioral: Nutrition Education
Azithromycin & Protein Supplement
Experimental group
Description:
Azithromycin / Protein-rich blended food / Nutrition education
Treatment:
Drug: Azithromycin Oral Product
Behavioral: Nutrition Education
Dietary Supplement: Protein Supplement
Azithromycin & Isocaloric Supplement
Experimental group
Description:
Azithromycin Isocaloric blended food Nutrition education
Treatment:
Dietary Supplement: Isocaloric Supplement
Drug: Azithromycin Oral Product
Behavioral: Nutrition Education
Azithromycin and Egg
Experimental group
Description:
Azithromycin Egg Nutrition education
Treatment:
Dietary Supplement: Egg
Drug: Azithromycin Oral Product
Behavioral: Nutrition Education

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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