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Periconceptional Surveillance in India

Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04048330
Enrollment
2000
Registered
2019-08-07
Start date
2018-04-07
Completion date
2024-12-31
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Folate Deficiency, Vitamin B12 Deficiency

Keywords

Anemia, Periconceptional, Vitamin B12, Folate, Surveillance, India

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.

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.

Interventions

None listed

Sponsors

Arogyavaram Medical Centre
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
St. John's Research Institute
CollaboratorOTHER
Cornell University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Vitamin B12 statusBaselineTotal vitamin B12 concentrations, pmol/L
HemoglobinBaselineHemoglobin concentrations, g/dL
Folate statusBaselineErythrocyte and serum folate concentrations, nmol/L

Secondary

MeasureTime frameDescription
AnemiaBaselineHemoglobin \<12.0 g/dL
Folate deficiency and insufficiencyBaselineErythrocyte (RBC) folate \<305 nmol/L; \<748 nmol/L
Vitamin B12 deficiency and insufficiencyBaselineTotal vitamin B12 \<148 pmol/L; \<221 pmol/L

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026