Salt-FA to Increase Folate Levels

Completed

• Conditions: Anencephaly-Spina Bifida; Folic Acid Deficiency; Neural Tube Defects; Spina Bifida

• Registration Number: NCT06174883
• Lead Sponsor: Hydrocephalus and Neuroscience Institute

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Pediatric Neurosurgery; 🇺🇸 Orlando, Florida, United States