Periconceptional Surveillance in India

NCT04048330 | Active Not Recruiting

• 1 other identifier: 76461
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anemia; Folate Deficiency; Vitamin B12 Deficiency

Keywords

Anemia; Periconceptional; Vitamin B12; Folate; Surveillance; India

Outcome Measures

Primary Outcomes (3)

• Hemoglobin

  Hemoglobin concentrations, g/dL

  Baseline

• Folate status

  Erythrocyte and serum folate concentrations, nmol/L

  Baseline

• Vitamin B12 status

  Total vitamin B12 concentrations, pmol/L

  Baseline

Secondary Outcomes (3)

• Anemia

  Baseline

• Folate deficiency and insufficiency

  Baseline

• Vitamin B12 deficiency and insufficiency

  Baseline

Study Arms (1)

Women of reproductive age

Women 15 to 49 years of age who are not pregnant or lactating

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Female
• Aged 15 to 49 years
• Currently not pregnant or lactating

You may not qualify if:

• \<15 or \>49 years old
• Currently pregnant or lactating

Sponsors & Collaborators

• Cornell University: lead
• Arogyavaram Medical Centre: collaborator
• Centers for Disease Control and Prevention: collaborator
• St. John's Research Institute: collaborator

Study Sites (1)

Arogyavaram Medical Centre

Madanapalle, Andhra Pradesh, India

Location

Related Publications (6)

• 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.

  PMID: 33122315 BACKGROUND

• Finkelstein 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.

  PMID: 34027296 RESULT

• Finkelstein 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.

  PMID: 35623855 RESULT

• Fothergill 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.

  PMID: 36130238 RESULT

• Fothergill 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.

  PMID: 37137617 RESULT

• Guetterman 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.

  PMID: 40349845 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens collected will include archived blood, saliva, urine, and stool samples

MeSH Terms

Conditions

Anemia; Folic Acid Deficiency; Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Julia L Finkelstein, MPH SM ScD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: April 7, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)