Anemia Clinical Trial
Official title:
Periconceptional Surveillance for Prevention of Anemia and Birth Defects in India
Verified date | March 2024 |
Source | Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | Arogyavaram Medical Centre | Madanapalle | Andhra Pradesh |
Lead Sponsor | Collaborator |
---|---|
Cornell University | Arogyavaram Medical Centre, Centers for Disease Control and Prevention, St. John's Research Institute |
India,
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
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 |
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