Periconceptional Surveillance in India

Anemia Clinical Trial

Official title:

Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04048330
• Other study ID #: 76461
• Status: Active, not recruiting
• Start date: April 7, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anemia
• Folate Deficiency
• Folic Acid Deficiency
• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Locations

Country	Name	City	State
India	Arogyavaram Medical Centre	Madanapalle	Andhra Pradesh

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	Arogyavaram Medical Centre, Centers for Disease Control and Prevention, St. John's Research Institute

Country where clinical trial is conducted

India, 

References & Publications (5)

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 N — View Citation

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. — View Citation

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 Populati — View Citation

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. — View Citation

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 concentrat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Hemoglobin concentrations, g/dL	Baseline
Primary	Folate status	Erythrocyte and serum folate concentrations, nmol/L	Baseline
Primary	Vitamin B12 status	Total vitamin B12 concentrations, pmol/L	Baseline
Secondary	Anemia	Hemoglobin <12.0 g/dL	Baseline
Secondary	Folate deficiency and insufficiency	Erythrocyte (RBC) folate <305 nmol/L; <748 nmol/L	Baseline
Secondary	Vitamin B12 deficiency and insufficiency	Total vitamin B12 <148 pmol/L; <221 pmol/L	Baseline