Salt-FA to Increase Folate Levels

Study Overview
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Brief Summary
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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
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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 : To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age. To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt consumption.

Official Title
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Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India

Conditions
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Neural Tube Defects, Folic Acid Deficiency, Spina Bifida, Anencephaly-Spina Bifida

Intervention / Treatment
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* Dietary Supplement: Folic acid fortified iodized salt


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Folic acid fortified iodized salt|addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure changes in median serum folate levels between baseline and study endpoint | evaluate blood levels pre- and post-intake of study salt (fortified with folic acid) | 2-6 months |