Periconceptional Surveillance in India

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India

Conditions
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Vitamin B12 Deficiency, Anemia, Folate Deficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 15 to 49 years Currently not pregnant or lactating Exclusion Criteria: <15 or >49 years old Currently pregnant or lactating

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women of reproductive age<br>Women 15 to 49 years of age who are not pregnant or lactating | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Periconceptional, Vitamin B12, Folate, Surveillance, India