An observational study in Neural Tube Defects, Folic Acid Deficiency and Spina Bifida, sponsored by Hydrocephalus and Neuroscience Institute. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Hydrocephalus and Neuroscience Institute · Observational
Question: How effective is fortified iodized salt in increasing serum concentrations of folate, B12 and iron among non-pregnant and non-lactating women of reproductive age?
Hypothesis: Micronutrient fortified iodized salt can increase serum levels (of folate, B12 and iron) and serve as a policy consideration in salt fortification with both iodine and other micronutrients to reduce serious and fatal birth defects.
Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid and other micronutrients (such as B12 and iron) through this dietary mechanism.
AIM:To assess increase in blood concentrations of folate, B12 and iron among women of reproductive age who consume micronutrient-fortified iodized salt for 3 months.
OBJECTIVES :
49 studies on the registry are indexed under Neural Tube Defects; 11 are open to participants now.
This study's enrollment of 200 is above the median of 123 across 22 observational studies indexed under Neural Tube Defects.
Browse Neural Tube Defects studies →This is the only study on the registry with Hydrocephalus and Neuroscience Institute as lead sponsor.
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Women of childbearing age who are non-lactating and willing to consume the study salt for the duration were recruited for voluntary participation into the study.
Inclusion Criteria: • Willing to voluntarily participate in the study
Exclusion Criteria:
addition of folic acid, B12 and iron to iodized salt to be consumed daily and assess rise in serum levels.
Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint
evaluate blood levels pre- and post-intake of study salt (fortified with folic acid, B12 and iron)
Time frame: 2-6 months
Plan to share: Undecided — redacted information will be made available upon request.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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