The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism

NCT ID: NCT03377777

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2014-11-30

Brief Summary

Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided. Excess serum was transported to UC Davis for metabolomics analysis and the University of Hohenheim for iron status assessment and measurement of inflammatory markers. Fecal samples were transported to UC Davis for measurement of the microbiome structure and function.

Detailed Description

Sample collection occurred between August and November 2014. A total of 203 infants and their parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the Moronacocha Health Center in Iquitos, Peru were recruited. All subjects were residents of Moronochocha, Iquitos, Loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g. Venous blood samples were collected by a lab technician at the local health center. Hemoglobin concentrations were immediately measured, and treatment given if warranted. Samples were subsequently transported to Selva Amazonica clinic, centrifuged, and serum was stored at -80 °C. Stool samples were collected by caregivers from diapers at home, taken to Selva Amazonica Clinic, and aliquoted. Fecal samples were analyzed for parasites at Selva Amazonica, and any necessary treatment was provided at the local health center. Serum and stool samples were shipped to UC Davis on dry ice, where they were stored at -80 °C until metabolomics and microbiome analyses. Serum aliquots were also shipped to the University of Hohenheim, Stuttgart, Germany for iron assessment, and measurement of inflammatory markers. All data integration and interpretation was performed at UC Davis.

Conditions

Anemia; Iron-deficiency; Iron Deficiency Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Infants

Outwardly healthy male and female infants at 6-7 months or 12-13 months. No intervention.

No intervention

Intervention Type: OTHER

Interventions

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Outwardly healthy,
• birthweight > 2,500 g
• term births
• residents in Moronacocha, Iquitos, Loreto

Exclusion Criteria

• Obvious signs of illness or malnutrition
• birthweight < 2,500 g
• preterm birth
• not a resident of Moronacocha, Iquitos, Loreto

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 13 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

Asociacion Civil Selva Amazonica

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

McClorry S, Zavaleta N, Llanos A, Casapia M, Lonnerdal B, Slupsky CM. Anemia in infancy is associated with alterations in systemic metabolism and microbial structure and function in a sex-specific manner: an observational study. Am J Clin Nutr. 2018 Dec 1;108(6):1238-1248. doi: 10.1093/ajcn/nqy249.

Reference Type: DERIVED

PMID: 30351381 (View on PubMed)

Other Identifiers

00000000

Identifier Type: OTHER

Identifier Source: secondary_id

GAIN08112014

Identifier Type: -

Identifier Source: org_study_id