AnemiaNCT04048330
Periconceptional Surveillance in India
An observational study of Anemia and Folate Deficiency, run by Cornell University at 1 site in India.
Trial summary
Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Folate Deficiency, Vitamin B12 Deficiency
- How many people
- 2,000 participants
- Where
- 1 siteIndia
- Study dates
- 7 Apr 2018to 31 Dec 2024
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: In order to obtain representative, population-level data in this setting, all rural households and a random subset of urban households in the catchment area will be selected for subsequent screening and recruitment of women for the biomarker study, with a target sample size of 2,000 women of reproductive age.
Who may be able to join
- Female
- Aged 15 to 49 years
- Currently not pregnant or lactating
Who cannot join
- <15 or >49 years old
- Currently pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India
Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India.
Read the detailed description
Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies due to social structures, and the physical demands of pregnancy and lactation particularly in South Asia. Inadequate periconceptional folate and vitamin B12 status are implicated in the development of birth defects and other pregnancy complications. Randomized trials established that periconceptional folic acid supplementation can prevent the occurrence and recurrence of neural tube defects, and fortification of staple foods with folic acid has been associated with decreasing neural tube defects in many countries around the globe. Red blood cell folate has been identified as a biomarker of neural tube defect risk at the population level, and increases in RBC folate concentrations predicted reductions in neural tube defect risk of up to 10-fold in USA, Chinese and Irish populations.
Emerging evidence has identified maternal vitamin B12 deficiency as a risk factor for neural tube defects, and vitamin B12 status may modify circulating folate biomarkers that predict neural tube defect risk. It is estimated that the burden of neural tube defects in India is among the highest in the world. However, there is little representative population-level data from Southern India. Surveillance programs are urgently needed to establish the burden of anaemia and key micronutrient deficiencies in settings such as Southern India to inform interventions for anemia and birth defects prevention.
The objective of this study is to conduct a biomarker survey of anemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India and to inform the development of a randomized trial for anemia and birth defects prevention. As part of this surveillance program, we are also establishing the World Health Organization-recommended microbiological assay for folate at our laboratory in Bangalore, India, and a WHO-SEARO site for birth defects surveillance in this setting. Findings from this pre-intervention biomarker survey will directly inform the development of a randomized efficacy trial of quadruple-fortified salt for the prevention of anemia and birth defects in Southern India and serve as the foundation for future public health programs to improve the health of women and young children in this population.
- Conditions
- Anemia, Folate Deficiency, Vitamin B12 Deficiency
- Keywords
- Anemia, Periconceptional, Vitamin B12, Folate, Surveillance, India
- Medical subject headings
- Anemia, Folic Acid Deficiency, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women of reproductive age | Women 15 to 49 years of age who are not pregnant or lactating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin concentrations, g/dL
Measured: Baseline
Folate status
Erythrocyte and serum folate concentrations, nmol/L
Measured: Baseline
Vitamin B12 status
Total vitamin B12 concentrations, pmol/L
Measured: Baseline
Secondary outcomes (3)
Anemia
Hemoglobin <12.0 g/dL
Measured: Baseline
Folate deficiency and insufficiency
Erythrocyte (RBC) folate <305 nmol/L; <748 nmol/L
Measured: Baseline
Vitamin B12 deficiency and insufficiency
Total vitamin B12 <148 pmol/L; <221 pmol/L
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start7 Apr 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Arogyavaram Medical Centre, Centers for Disease Control and Prevention, St. John's Research Institute
- Responsible party
- Sponsor
- Investigators
- Julia L Finkelstein, MPH SM ScD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048330
- Sponsor's protocol ID
- 76461
- Status last verified
- Mar 2024
- First submitted
- 6 Aug 2019
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finkelstein JL, Fothergill A, Johnson CB, Guetterman HM, Bose B, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Rose CE, Krisher JT, Ruth CJ, Mehta R, Williams JL, Bonam W, Crider KS. Periconceptional surveillance for prevention of anaemia and birth defects in Southern India: protocol for a biomarker survey in women of reproductive age. BMJ Open. 2020 Oct 29;10(10):e038305. doi: 10.1136/bmjopen-2020-038305.
PubMed 33122315Finkelstein JL, Fothergill A, Johnson CB, Guetterman HM, Bose B, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Rose CE, Williams JL, Bonam W, Crider KS. Anemia and Vitamin B-12 and Folate Status in Women of Reproductive Age in Southern India: Estimating Population-Based Risk of Neural Tube Defects. Curr Dev Nutr. 2021 Apr 26;5(5):nzab069. doi: 10.1093/cdn/nzab069. eCollection 2021 May.
PubMed 34027296Finkelstein JL, Fothergill A, Guetterman HM, Johnson CB, Bose B, Qi YP, Rose CE, Williams JL, Mehta S, Kuriyan R, Bonam W, Crider KS. Iron status and inflammation in women of reproductive age: A population-based biomarker survey and clinical study. Clin Nutr ESPEN. 2022 Jun;49:483-494. doi: 10.1016/j.clnesp.2022.02.123. Epub 2022 Mar 5.
PubMed 35623855Fothergill A, Crider KS, Johnson CB, Raj MP, Guetterman HM, Bose B, Rose CE, Qi YP, Williams JL, Kuriyan R, Bonam W, Finkelstein JL. Comparison of Anemia Screening Methods Using Paired Venous Samples in Women of Reproductive Age in Southern India. J Nutr. 2023 Jan 14;152(12):2978-2992. doi: 10.1093/jn/nxac218.
PubMed 36130238Fothergill A, Crider KS, Rose CE, Bose B, Guetterman HM, Johnson CB, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Williams JL, Kuriyan R, Bonam W, Finkelstein JL. Estimating the serum folate concentration that corresponds to the red blood cell folate concentration threshold associated with optimal neural tube defects prevention: A population-based biomarker survey in Southern India. Am J Clin Nutr. 2023 May;117(5):985-997. doi: 10.1016/j.ajcnut.2023.01.016. Epub 2023 Apr 19.
PubMed 37137617Guetterman HM, Crider KS, Fothergill A, Bose B, Johnson CB, Jabbar S, Zhang M, Pfeiffer CM, Rose CE, Qi YP, Williams JL, Mehta S, Kuriyan R, Finkelstein JL. Vitamin B12 status and metabolic health in women of reproductive age: Population-based biomarker survey. Clin Nutr ESPEN. 2025 Aug;68:176-188. doi: 10.1016/j.clnesp.2025.05.011. Epub 2025 May 9.
PubMed 40349845
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India
- ClinicalTrials.gov ID
- NCT04048330
- Acronym / sponsor ID
- 76461
- Conditions
- Anemia, Folate Deficiency, Vitamin B12 Deficiency
- Keywords
- Anemia, Periconceptional, Vitamin B12, Folate, Surveillance, India
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Arogyavaram Medical Centre, Centers for Disease Control and Prevention, St. John's Research Institute
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 2019 (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.
Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India.
Detailed description
Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies due to social structures, and the physical demands of pregnancy and lactation particularly in South Asia. Inadequate periconceptional folate and vitamin B12 status are implicated in the development of birth defects and other pregnancy complications. Randomized trials established that periconceptional folic acid supplementation can prevent the occurrence and recurrence of neural tube defects, and fortification of staple foods with folic acid has been associated with decreasing neural tube defects in many countries around the globe. Red blood cell folate has been identified as a biomarker of neural tube defect risk at the population level, and increases in RBC folate concentrations predicted reductions in neural tube defect risk of up to 10-fold in USA, Chinese and Irish populations.
Emerging evidence has identified maternal vitamin B12 deficiency as a risk factor for neural tube defects, and vitamin B12 status may modify circulating folate biomarkers that predict neural tube defect risk. It is estimated that the burden of neural tube defects in India is among the highest in the world. However, there is little representative population-level data from Southern India. Surveillance programs are urgently needed to establish the burden of anaemia and key micronutrient deficiencies in settings such as Southern India to inform interventions for anemia and birth defects prevention.
The objective of this study is to conduct a biomarker survey of anemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India and to inform the development of a randomized trial for anemia and birth defects prevention. As part of this surveillance program, we are also establishing the World Health Organization-recommended microbiological assay for folate at our laboratory in Bangalore, India, and a WHO-SEARO site for birth defects surveillance in this setting. Findings from this pre-intervention biomarker survey will directly inform the development of a randomized efficacy trial of quadruple-fortified salt for the prevention of anemia and birth defects in Southern India and serve as the foundation for future public health programs to improve the health of women and young children in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of reproductive age | – | –Women 15 to 49 years of age who are not pregnant or lactating |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In order to obtain representative, population-level data in this setting, all rural households and a random subset of urban households in the catchment area will be selected for subsequent screening and recruitment of women for the biomarker study, with a target sample size of 2,000 women of reproductive age.
Key inclusion criteria (3 listed)
- Female
- Aged 15 to 49 years
- Currently not pregnant or lactating
Key exclusion criteria (2 listed)
- <15 or >49 years old
- Currently pregnant or lactating
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
Hemoglobin
Time frame: Baseline
Hemoglobin concentrations, g/dL
Folate status
Time frame: Baseline
Erythrocyte and serum folate concentrations, nmol/L
Vitamin B12 status
Time frame: Baseline
Total vitamin B12 concentrations, pmol/L
3 secondary outcomes
Anemia
Time frame: Baseline
Folate deficiency and insufficiency
Time frame: Baseline
Vitamin B12 deficiency and insufficiency
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 33122315Finkelstein JL, Fothergill A, Johnson CB, Guetterman HM, Bose B, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Rose CE, Krisher JT, Ruth CJ, Mehta R, Williams JL, Bonam W, Crider KS. Periconceptional surveillance for prevention of anaemia and birth defects in Southern India: protocol for a biomarker survey in women of reproductive age. BMJ Open. 2020 Oct 29;10(10):e038305. doi: 10.1136/bmjopen-2020-038305.
- Results publication: PubMed 34027296Finkelstein JL, Fothergill A, Johnson CB, Guetterman HM, Bose B, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Rose CE, Williams JL, Bonam W, Crider KS. Anemia and Vitamin B-12 and Folate Status in Women of Reproductive Age in Southern India: Estimating Population-Based Risk of Neural Tube Defects. Curr Dev Nutr. 2021 Apr 26;5(5):nzab069. doi: 10.1093/cdn/nzab069. eCollection 2021 May.
- Results publication: PubMed 35623855Finkelstein JL, Fothergill A, Guetterman HM, Johnson CB, Bose B, Qi YP, Rose CE, Williams JL, Mehta S, Kuriyan R, Bonam W, Crider KS. Iron status and inflammation in women of reproductive age: A population-based biomarker survey and clinical study. Clin Nutr ESPEN. 2022 Jun;49:483-494. doi: 10.1016/j.clnesp.2022.02.123. Epub 2022 Mar 5.
- Results publication: PubMed 36130238Fothergill A, Crider KS, Johnson CB, Raj MP, Guetterman HM, Bose B, Rose CE, Qi YP, Williams JL, Kuriyan R, Bonam W, Finkelstein JL. Comparison of Anemia Screening Methods Using Paired Venous Samples in Women of Reproductive Age in Southern India. J Nutr. 2023 Jan 14;152(12):2978-2992. doi: 10.1093/jn/nxac218.
- Results publication: PubMed 37137617Fothergill A, Crider KS, Rose CE, Bose B, Guetterman HM, Johnson CB, Jabbar S, Zhang M, Pfeiffer CM, Qi YP, Williams JL, Kuriyan R, Bonam W, Finkelstein JL. Estimating the serum folate concentration that corresponds to the red blood cell folate concentration threshold associated with optimal neural tube defects prevention: A population-based biomarker survey in Southern India. Am J Clin Nutr. 2023 May;117(5):985-997. doi: 10.1016/j.ajcnut.2023.01.016. Epub 2023 Apr 19.
- Derived from this study: PubMed 40349845Guetterman HM, Crider KS, Fothergill A, Bose B, Johnson CB, Jabbar S, Zhang M, Pfeiffer CM, Rose CE, Qi YP, Williams JL, Mehta S, Kuriyan R, Finkelstein JL. Vitamin B12 status and metabolic health in women of reproductive age: Population-based biomarker survey. Clin Nutr ESPEN. 2025 Aug;68:176-188. doi: 10.1016/j.clnesp.2025.05.011. Epub 2025 May 9.
- 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.
Julia L Finkelstein, MPH SM ScD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Folate Deficiency, run by Cornell University at 1 site in India.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Hemoglobin (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT04048330, which also lists 6 linked publications.
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 1 Apr 2024.