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Periconceptional Surveillance in India

Sponsor
Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04048330
Collaborator
Arogyavaram Medical Centre (Other), Centers for Disease Control and Prevention (U.S. Fed), St. John's Research Institute (Other)
2,000
Enrollment
1
Location
54
Anticipated Duration (Months)
37.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies, and there is increasing evidence of the role of periconceptional nutritional status in the risk of birth defects and other pregnancy complications. However, there is limited population-based data from India, where the burden and consequences of these deficiencies is unacceptably high. The objective of this study is to conduct a population-based biomarker survey to determine the burden of anemia and vitamin B12 and folate status in women of reproductive age, as part of a periconceptional surveillance program in Southern India. Findings from this biomarker survey will establish the burden of anemia and B-vitamin deficiencies in women of reproductive age, and inform the development of a randomized efficacy trial of quadruple-fortified salt for the prevention of anemia and birth defects in Southern India.

Condition or Disease Intervention/Treatment Phase

    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. Periconceptional vitamin B12 and folate status are implicated in the development of birth defects and other pregnancy complications. Preliminary findings from clinical populations suggest that vitamin B12 and folate deficiencies early in pregnancy are the leading nutritional causes for neural tube defects. However, there is little representative population-level data from Southern India. Surveillance programs are urgently needed to establish the burden of anemia and key micronutrient deficiencies in high-burden settings such as Southern India, and to inform the development of interventions for anemia and birth defects prevention.

    The objective of this study is to conduct a biomarker survey to determine the burden of anemia and vitamin B12 and folate status in women of reproductive age, as part of an ongoing periconceptional surveillance program in Southern India. The goals of this surveillance program are to establish the World Health Organization (WHO)-recommended microbiologic assay for folate in Southern India, to determine the burden of anemia and B-vitamin deficiencies in women of reproductive age, and to inform the development of a randomized trial of quadruple-fortified salt for anemia and birth defects prevention in Southern India. This laboratory will also serve as the foundation for future intervention trials and public health programs to improve the health of women and young children in this population.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India
    Actual Study Start Date :
    Apr 7, 2018
    Anticipated Primary Completion Date :
    Oct 6, 2022
    Anticipated Study Completion Date :
    Oct 6, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Women of reproductive age

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

    Outcome Measures

    Primary Outcome Measures

    1. Hemoglobin [Baseline]

      Hemoglobin concentrations, g/dL

    2. Folate status [Baseline]

      Erythrocyte and serum folate concentrations, nmol/L

    3. Vitamin B12 status [Baseline]

      Total vitamin B12 concentrations, pmol/L

    Secondary Outcome Measures

    1. Anemia [Baseline]

      Hemoglobin <12.0 g/dL

    2. Folate deficiency and insufficiency [Baseline]

      Erythrocyte (RBC) folate <305 nmol/L; <748 nmol/L

    3. Vitamin B12 deficiency and insufficiency [Baseline]

      Total vitamin B12 <148 pmol/L; <221 pmol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Female

    • Aged 15 to 49 years

    • Currently not pregnant or lactating

    Exclusion Criteria:

    • <15 or >49 years old

    • Currently pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arogyavaram Medical Centre Madanapalle Andhra Pradesh India

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Julia L Finkelstein, MPH SM ScD, Cornell University
    • Principal Investigator: Rebecca Kuriyan, PhD, St. John's Research Institute
    • Principal Investigator: Wesley Bonam, MBBS, Arogyavaram Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cornell University
    ClinicalTrials.gov Identifier:
    NCT04048330
    Other Study ID Numbers:
    • 76461
    First Posted:
    Aug 7, 2019
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cornell University
    Anemia
    Periconceptional
    Vitamin B12
    Folate
    Surveillance
    India
    Additional relevant MeSH terms:
    Anemia
    Vitamin B 12 Deficiency
    Folic Acid Deficiency

    Study Results

    No Results Posted as of Jun 7, 2022