Salt-FA to Increase Folate Levels

Hydrocephalus and Neuroscience Institute

Status: Completed

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

Treatments: Dietary Supplement: Folic acid fortified iodized salt

Study type: Observational

Funder types: Other

Identifiers

NCT06174883

DFS-1-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)