Iron-deficiencyNHANESNCT03274726
Iron Status of Women and Young Children in the United States
An observational study of Iron-deficiency and Nutritional Deficiency, run by Centers for Disease Control and Prevention.
Trial summary
This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women. Read more about this study
- Who is it for?
- Ages 12 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Nutritional Deficiency
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 1 Dec 2010
- 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 12 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Included:
- Children ages 12-23 months and Women ages 12-49 years
- Those who completed the MEC
Excluded:
- Those missing data on iron biomarkers
About this study
Official title: Iron Status of Toddlers, Non-pregnant, and Pregnant Women in the United States
This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.
Read the detailed description
Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of populations in the United States.
Objective: This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.
Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010), non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES 1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce prevalence estimates of ID and IDA for each target population. All analyses were weighted to account for the complex survey design
- Conditions
- Iron-deficiency, Nutritional Deficiency
- Medical subject headings
- Anemia, Iron-Deficiency, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Deficiency
Total Body Iron <0 mg/kg
Measured: 1999-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Jan 1999
- Primary completion1 Dec 2010
- Study completion1 Dec 2010
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 Iron-deficiencyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Priya Gupta, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274726
- Sponsor's protocol ID
- CDC-NCCDPHP-2011-17
- Acronym
- NHANES
- Status last verified
- May 2024
- First submitted
- 5 Sep 2017
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gupta PM, Hamner HC, Suchdev PS, Flores-Ayala R, Mei Z. Iron status of toddlers, nonpregnant females, and pregnant females in the United States. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1640S-1646S. doi: 10.3945/ajcn.117.155978. Epub 2017 Oct 25.
PubMed 29070559
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Status of Toddlers, Non-pregnant, and Pregnant Women in the United States
- ClinicalTrials.gov ID
- NCT03274726
- Acronym / sponsor ID
- NHANES / CDC-NCCDPHP-2011-17
- Conditions
- Iron-deficiency, Nutritional Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Dec 2010 (actual)
- First posted
- 7 Sep 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.
This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.
Detailed description
Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of populations in the United States.
Objective: This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.
Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010), non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES 1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce prevalence estimates of ID and IDA for each target population. All analyses were weighted to account for the complex survey design
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Iron Deficiency
Time frame: 1999-2010
Total Body Iron <0 mg/kg
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 23 May 2024.
- Derived from this study: PubMed 29070559Gupta PM, Hamner HC, Suchdev PS, Flores-Ayala R, Mei Z. Iron status of toddlers, nonpregnant females, and pregnant females in the United States. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1640S-1646S. doi: 10.3945/ajcn.117.155978. Epub 2017 Oct 25.
Related trials for Iron-deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
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 Iron-deficiency and Nutritional Deficiency, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 May 2024. 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?
Iron Deficiency (time frame: 1999-2010). 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 NCT03274726, 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 23 May 2024.