Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2022-06-01
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Folic acid fortified iodized salt
addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Hydrocephalus and Neuroscience Institute
OTHER
Responsible Party
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Principal Investigators
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Jogi Pattisapu, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Neurosurgery
Locations
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Pediatric Neurosurgery
Orlando, Florida, United States
Countries
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References
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Pattisapu JV, Manda VV, Kottakki MNR, Kajana PM, Kancherla V, Bhaganagarapu HR, Veerappan V, Ediga A, Mannar V, Diosady L, Oakley GP Jr. Folic Acid-Fortified Iodized Salt and Serum Folate Levels in Reproductive-Aged Women of Rural India: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241777. doi: 10.1001/jamanetworkopen.2024.1777.
Other Identifiers
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DFS-1-2022
Identifier Type: -
Identifier Source: org_study_id