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Assessing the Impact of Fortification on the Epidemiology of Neural Tube Defects

Assessing the Impact of Fortification on the Epidemiology of Neural Tube Defects FDA Advisory Committee for Reproductive Health Drugs December 15, 2003. Joseph Mulinare, M.D., M.S.P.H. National Center on Birth Defects and Developmental Disabilities. Outline.

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Assessing the Impact of Fortification on the Epidemiology of Neural Tube Defects

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  1. Assessing the Impact of Fortification on the Epidemiology of Neural Tube Defects FDA Advisory Committee for Reproductive Health Drugs December 15, 2003 Joseph Mulinare, M.D., M.S.P.H. National Center on Birth Defects and Developmental Disabilities

  2. Outline • Background: NTD prevention using folic acid • Ways to achieve adequate folate levels for prevention • Blood folate results • Neural tube defect prevalence • Concluding remarks

  3. Serious birth defects spina bifida and anencephaly 1 of 1,000 pregnancies 300,000 yearly worldwide Increased consumption of folic acid can prevent 50%-70% Neural tube defects From NEJM 1999

  4. Randomized trials Non-randomized trials Observational studies 800μg MV '92-Hungary '93-New England '95-California N 400μg FA S '99-P.R. China Risk Reduction Folic Acid – Neural Tube Defect Studies 1980-1999 Decreased risk Increased risk '80-England T '81-S. Wales T '88-Atlanta '89-W. Australia '89-CA/Illinois '89-Boston '90-Cuba T 4000μg FA '91-UK-MRC T 600 0% 100% 80% 60% 40% 20% 120% 500 Percent Risk Reduction / Increase with 95% CI

  5. 1992 U.S. Public Health Service Folic Acid Recommendation • All women capable of becoming • pregnant should consume - 400 micrograms (0.4mg) folic acid daily - to reduce their risk of a pregnancy affected by spina bifida or other neural tube defects (NTDs)

  6. 1992 U.S. Public Health Service Folic Acid Recommendation • Increase consumption of folic acid/folate: • Improve dietary habits • Take daily folic acid supplement • Consume fortified foods

  7. Ways of achieving adequate folic acid • Promote supplement use: CDC, IOM, MoD,NCFA,states, local agencies • - use health communication and education efforts

  8. Use and Knowledge of Folic Acid Women of Childbearing Age 1995 2003 52% 79% Heard of folic acid Knew FA can prevent birth defects 9% 13% Knew FA should be taken before pregnancy 2% 7% 28% 32% Took folic acid daily March of Dimes Birth Defects Foundation, Gallup Polls 1995, 2003

  9. Percent women taking vitamin with folic acid daily All women age 18-45 50 40 34% 33% 32% 32% 32% 29% 28% 30 Percent 20 10 0 1995 1997 1998 2000 2001 2002 2003

  10. Ways of achieving adequate folic acid • Promoted supplement use: CDC, IOM, MoD NCFA, states, local agencies • - use health communication and education efforts • Mandated fortification: FDA (1998) • - Add folic acid to all products made with “enriched” flour to contain 140 ug/100g • -Approve the use of health claims on products that contain “significant” amounts of folic acid • Added folic acid: Breakfast cereal manufacturers • - Folic acid increased to 100% DV

  11. ng/mL Red blood cell folate 350 263.6 300 250 200 159.9 150 100 50 0 Before After Median serum and red blood cell folate levels, before and after folic acid fortification, U.S. women, aged 15-44 years, NHANES ng/mL Serum folate 20 15 13.0 10 4.0 5 0 Before After SOURCE: CDC/NCHS, National Health and Nutrition Examination Surveys, 1988-94 and 1999-2000

  12. Change in U.S. NTD birth prevalence per 10,000 by fortification status (NCHS Birth Certificate Data, 45 states) Before None After Mandatory PR (95% CI) % decline Spina bifida 2.62 2.02 23% 0.77 (0.70-0.84) Anencephaly 1.16 1.03 11% 0.89 (0.78-0.95)

  13. Change in U.S. NTD prevalence per 10,000 by fortification status (NBDPN, 24 programs) Before None After Mandatory PR (95% CI) % decline Spina bifida 5.1 3.5 33% 0.67 (0.63-0.73) Anencephaly 2.5 2.1 14% 0.86 (0.78-0.95)

  14. Evaluation of the change in NTD prevalence, U.S. Goal - NTD % decline Actual NTD % decline U.S. 50%-70% 20%-30%

  15. Folic Acid Preventable Neural Tube Defects Are we done yet? 4000 estimated NTD-affected pregnancies yearly 2000 50% of NTD-affected pregnancies that are preventable - ~1000 estimated 25% fewer NTD pregnancies. due to fortification ~1000 estimate NTD-affected pregnancies remaining that are folic acid preventable

  16. Concluding remarks: • Blood folate levels have increased substantially • since food fortification began in 1998. • NTD prevalence has fallen 20% - 30% in the United States. • Lower NTD rates are consistent with an increase in • folic acid content from food fortification. • The need still exists to prevent the occurrence of an • additional 1,000 NTD-affected pregnancies… • 1,000 additional babies who can be born healthy, without the • devastating effects caused by these serious birth defects

  17. Concluding remarks (contd): • More options are needed to provide additional folic acid to ALL reproductive-age women who are at risk for having a folic-acid-preventable neural tube defect. • We should be doing whatever is necessary to • safely increase the amounts of folic acid that women • of reproductive age need to get to eliminate all • folic-acid preventable birth defects.

  18. National Folic Acid Campaign to Prevent Birth Defects, 1999 -

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