CompletedNot Applicable

Using Iodized Salt to Improve Serum Folate, B12 and Iron Levels

United States, India200 participantsStarted 2022-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 micronutrient supplements 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)

What they're measuring

Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint

Timeframe: 2-6 months

Trial details

NCT IDNCT06904612

SponsorHydrocephalus and Neuroscience Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-30

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