AnemiaNCT03377777
The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism
An observational study of Anemia and Iron-deficiency, run by University of California, Davis.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency, Iron Deficiency Anemia
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 30 Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Outwardly healthy 6-7 month, and 12-13 month male and female infants born at term with a birthweight > 2,500 g.
Who may be able to join
- Outwardly healthy,
- birthweight > 2,500 g
- term births
- residents in Moronacocha, Iquitos, Loreto
Who cannot join
- Obvious signs of illness or malnutrition
- birthweight < 2,500 g
- preterm birth
- not a resident of Moronacocha, Iquitos, Loreto
About this study
Official title: Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.
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.
Read the 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
- Being tested
- No intervention
- Keywords
- Anemia, Iron-deficiency, Iron-deficiency anemia, Infants, Metabolomics, Microbiome
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Infants | Outwardly healthy male and female infants at 6-7 months or 12-13 months. No intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia status
Anemia status [Hb] ≤ 110 g/L
Measured: 6-7 months or 12-13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Aug 2014
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, Asociacion Civil Selva Amazonica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377777
- Sponsor's protocol ID
- GAIN08112014
- Other IDs
- 00000000
- Status last verified
- Jan 2018
- First submitted
- 11 Dec 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Microbiome sequencing data will be shared in a public repository (with iron status included as meta data).
Publications
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.
PubMed 30351381
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.
- ClinicalTrials.gov ID
- NCT03377777
- Acronym / sponsor ID
- GAIN08112014
- Conditions
- Anemia, Iron-deficiency, Iron Deficiency Anemia
- Keywords
- Anemia, Iron-deficiency, Iron-deficiency anemia, Infants, Metabolomics, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, Asociacion Civil Selva Amazonica
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | Other: No interventionOutwardly healthy male and female infants at 6-7 months or 12-13 months. No intervention. |
Who may qualify
- Ages
- 6 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Outwardly healthy 6-7 month, and 12-13 month male and female infants born at term with a birthweight > 2,500 g.
Key inclusion criteria (4 listed)
- Outwardly healthy,
- birthweight > 2,500 g
- term births
- residents in Moronacocha, Iquitos, Loreto
Key exclusion criteria (4 listed)
- Obvious signs of illness or malnutrition
- birthweight < 2,500 g
- preterm birth
- not a resident of Moronacocha, Iquitos, Loreto
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Infants |
Primary outcome
Anemia status
Time frame: 6-7 months or 12-13 months
Anemia status [Hb] ≤ 110 g/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 30351381McClorry 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.
- Individual participant dataSharing planned: Yes. Microbiome sequencing data will be shared in a public repository (with iron status included as meta data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Iron-deficiency, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia status (time frame: 6-7 months or 12-13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.