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

NCT03377777 | Completed

• 2 other identifiers: GAIN0811201400000000
• Study Type: observational
• Target: 203
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Iron-deficiency; Iron Deficiency Anemia

Keywords

Anemia; Iron-deficiency; Iron-deficiency anemia; Infants; Metabolomics; Microbiome

Outcome Measures

Primary Outcomes (1)

• Anemia status

  Anemia status \[Hb\] ≤ 110 g/L

  6-7 months or 12-13 months

Study Arms (1)

Infants

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

Other: No intervention

Interventions

No intervention OTHER

Infants

Eligibility Criteria

• Age: 6 Months - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Outwardly healthy 6-7 month, and 12-13 month male and female infants born at term with a birthweight \> 2,500 g.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• Universidad Peruana Cayetano Heredia: collaborator
• Asociacion Civil Selva Amazonica: collaborator

Related Publications (1)

• 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.

  PMID: 30351381 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: August 1, 2014
• Primary Completion: November 30, 2014
• Study Completion: November 30, 2014
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once study has been published
• Access Criteria: Publicly available