AnemiaNCT04820465
Anemia in Older Adults
An observational study of Anemia and Nutritional Deficiency, run by Instituto Nacional de Salud Publica, Mexico.
Trial summary
A cross-sectional study with 829 older Mexican adults were recruited from July to September 2015, from four localities in the southern region of México. Older adults were interviewed at their homes and a fasting blood sample was obtained for analysis of micronutrient status (iron deficiency, vitamin B12 deficiency… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Nutritional Deficiency, Inflammation
- What is being tested?
- Non available due to cross-sectional study design
- How many people
- 829 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Sep 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults >=60 years living in urban localities from the southern region of Mexico ( Champotón, Valladolid, Campeche and Yucatán) were visited at their homes. 60% of the total sample were women and the rest men.
Who may be able to join
- Community-dwelling older adults who wish to participate in the study
- Ambulatory older adultos
- Older adult with own decision making
Who cannot join
- Non demented
- Non oxygen dependent
- No disability
About this study
Official title: Identification of the Main Causes of Anemia in Older Adults
A cross-sectional study with 829 older Mexican adults were recruited from July to September 2015, from four localities in the southern region of México. Older adults were interviewed at their homes and a fasting blood sample was obtained for analysis of micronutrient status (iron deficiency, vitamin B12 deficiency, folate deficiency, vitamin A deficiency and biomarkers of inflammation). The aim of the study was to identify the main causes of anemia in older adults with higher rates of anemia according to the recent data of the Mexican National Health and Nutrition Survey.
Read the detailed description
A survey with cross-sectional design was applied in 829 older Mexican adults, recruited during the period July to September 2015, from four localities in the southern region of México: including Champotón, Campeche, Mérida, and Valladolid. Older adults were interviewed at their homes to collect nutrition, health, cognitive and dietary information. Anthropometric measures and functionallity tests were also collected. A finger prick capillary blood sample was collected to measure hemoblobin in situ using HemoCue. Anemia was defined according to WHO criteria. A fasting venous blood sample was collected in 803 older adults. Serum was separated and frozen at -20°C to measure ferritin, retinol, vitamin B12, folate, iron, soluble transferrin receptor, C-reactive protein, interleukin 6, alpha glycoprotein 1, hepcidin, erythropoietin in the laboratory of nutrition of the National Institute of Public Health.
The study protocol was approved by Research, Biosecurity and Ethics Committees of the National Institute of Public Health. Participants received a detailed explanation of the study procedures and signed an informed consent form prior to data collection.
- Conditions
- Anemia, Nutritional Deficiency, Inflammation
- Being tested
- Non available due to cross-sectional study design
- Keywords
- Anemia, Older mexican adults, Vitamin A deficiency, Iron deficiency, Vitamin B12 deficiency
- Medical subject headings
- Anemia, Malnutrition, Inflammation, Vitamin A Deficiency, Iron Deficiencies, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non available due to cross-sectional study designOther
Non available since this study (survey) has a cross-sectional design
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Hemoglobin measure in capillary blood sample
Measured: July- September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa De la Cruz, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820465
- Sponsor's protocol ID
- S0008-2014-1 - 000000000234157
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez RP, De la Cruz-Gongora V, Rodriguez AS. Serum retinol levels are associated with cognitive function among community-dwelling older Mexican adults. Nutr Neurosci. 2022 Sep;25(9):1881-1888. doi: 10.1080/1028415X.2021.1913315. Epub 2021 Apr 13.
PubMed 33847257
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Main Causes of Anemia in Older Adults
- ClinicalTrials.gov ID
- NCT04820465
- Acronym / sponsor ID
- S0008-2014-1 - 000000000234157
- Conditions
- Anemia, Nutritional Deficiency, Inflammation
- Keywords
- Anemia, Older mexican adults, Vitamin A deficiency, Iron deficiency, Vitamin B12 deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Mar 2021 (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.
A cross-sectional study with 829 older Mexican adults were recruited from July to September 2015, from four localities in the southern region of México. Older adults were interviewed at their homes and a fasting blood sample was obtained for analysis of micronutrient status (iron deficiency, vitamin B12 deficiency, folate deficiency, vitamin A deficiency and biomarkers of inflammation). The aim of the study was to identify the main causes of anemia in older adults with higher rates of anemia according to the recent data of the Mexican National Health and Nutrition Survey.
Detailed description
A survey with cross-sectional design was applied in 829 older Mexican adults, recruited during the period July to September 2015, from four localities in the southern region of México: including Champotón, Campeche, Mérida, and Valladolid. Older adults were interviewed at their homes to collect nutrition, health, cognitive and dietary information. Anthropometric measures and functionallity tests were also collected. A finger prick capillary blood sample was collected to measure hemoblobin in situ using HemoCue. Anemia was defined according to WHO criteria. A fasting venous blood sample was collected in 803 older adults. Serum was separated and frozen at -20°C to measure ferritin, retinol, vitamin B12, folate, iron, soluble transferrin receptor, C-reactive protein, interleukin 6, alpha glycoprotein 1, hepcidin, erythropoietin in the laboratory of nutrition of the National Institute of Public Health.
The study protocol was approved by Research, Biosecurity and Ethics Committees of the National Institute of Public Health. Participants received a detailed explanation of the study procedures and signed an informed consent form prior to data collection.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults >=60 years living in urban localities from the southern region of Mexico ( Champotón, Valladolid, Campeche and Yucatán) were visited at their homes. 60% of the total sample were women and the rest men.
Key inclusion criteria (3 listed)
- Community-dwelling older adults who wish to participate in the study
- Ambulatory older adultos
- Older adult with own decision making
Key exclusion criteria (3 listed)
- Non demented
- Non oxygen dependent
- No disability
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 |
|---|---|---|
| Non available due to cross-sectional study designNon available since this study (survey) has a cross-sectional design | Other | – |
Primary outcome
Anemia
Time frame: July- September 2015
Hemoglobin measure in capillary blood sample
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 29 Mar 2021.
- Derived from this study: PubMed 33847257Gonzalez RP, De la Cruz-Gongora V, Rodriguez AS. Serum retinol levels are associated with cognitive function among community-dwelling older Mexican adults. Nutr Neurosci. 2022 Sep;25(9):1881-1888. doi: 10.1080/1028415X.2021.1913315. Epub 2021 Apr 13.
- Individual participant dataSharing planned: No
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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 Nutritional Deficiency, run by Instituto Nacional de Salud Publica, Mexico.
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 3 inclusion and 3 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 29 Mar 2021. 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 (time frame: July- September 2015). 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 NCT04820465, 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 29 Mar 2021.