Clinical trial NCT06904612: Using Salt to Improve Micronutrient Status
Official title: Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neural Tube Defects
Folic Acid Deficiency
Spina Bifida
Anencephaly-Spina Bifida
Lead sponsor: Hydrocephalus and Neuroscience Institute
Sponsor class: OTHER
Collaborators: name: Andhra Medical College
First posted: 2025-04-01
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 assess acceptance of study salt for daily use during 3 months of consumption.

Eligibility criteria: 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)

Primary outcomes:
measure: Measure changes in median serum folate levels between baseline and study endpoint
timeFrame: 2-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pediatric Neurosurgery
state: Florida
city: Visakhapatnam
country: India
facility: Andhra Medical College
state: Andhra Pradesh
Study officials:
affiliation: Pediatric Neurosurgery
name: Jogi Pattisapu, MD
role: PRINCIPAL_INVESTIGATOR
References: