Anencephaly-Spina Bifida, Folic Acid Deficiency, Neural Tube Defects, Spina Bifida
Conditions
Brief summary
Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.
Detailed description
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 through this dietary mechanism. AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt. OBJECTIVES : 1. To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age. 2. To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt consumption.
Interventions
DIETARY_SUPPLEMENTFolic acid fortified iodized salt
addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.
Sponsors
Hydrocephalus and Neuroscience Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• Willing to voluntarily participate in the study * Can comprehend and comply with study requirements * Aged between 18 and 45 years. * No documented issues with child bearing potential * Resident of the area of study for duration of study. * Consume only study salt during study
Exclusion criteria
* Taking multivitamins or FA during study * Pregnant or lactating at recruitment or during study * Co-morbidities such as Malabsorption disorders, severe anemia (Hgb \<8.0 g/dL), uncontrolled hypertension, (SBP ≥140 mm Hg or DBP ≥90 mm Hg), HIV, active TB or malaria infection * History of prior SBA delivery * Pre-existing medical conditions (i.e., cancer or need for regular medications)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure changes in median serum folate levels between baseline and study endpoint | 2-6 months | evaluate blood levels pre- and post-intake of study salt (fortified with folic acid) |
Countries
United States
Outcome results
None listed