Periconceptional Surveillance in India

March 29, 2024 updated by: Cornell University

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Madanapalle, Andhra Pradesh, India
        • Arogyavaram Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women of reproductive age
Women 15 to 49 years of age who are not pregnant or lactating

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: Baseline
Hemoglobin concentrations, g/dL
Baseline
Folate status
Time Frame: Baseline
Erythrocyte and serum folate concentrations, nmol/L
Baseline
Vitamin B12 status
Time Frame: Baseline
Total vitamin B12 concentrations, pmol/L
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: Baseline
Hemoglobin <12.0 g/dL
Baseline
Folate deficiency and insufficiency
Time Frame: Baseline
Erythrocyte (RBC) folate <305 nmol/L; <748 nmol/L
Baseline
Vitamin B12 deficiency and insufficiency
Time Frame: Baseline
Total vitamin B12 <148 pmol/L; <221 pmol/L
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

Centers for Disease Control and Prevention
St. John's Research Institute
Arogyavaram Medical Centre

Investigators

  • Principal Investigator: Julia L Finkelstein, MPH SM ScD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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