Salt-FA to Increase Folate Levels

Spina Bifida Clinical Trial

Official title:

Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06174883
• Other study ID #: DFS-1-2022
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2023
• Source: Hydrocephalus and Neuroscience Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anencephaly
• Folic Acid Deficiency
• Neural Tube Defects
• Spina Bifida
• Spinal Dysraphism

Intervention

Dietary Supplement:
• Folic acid fortified iodized salt
addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.

Locations

Country	Name	City	State
United States	Pediatric Neurosurgery	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hydrocephalus and Neuroscience Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure changes in median serum folate levels between baseline and study endpoint	evaluate blood levels pre- and post-intake of study salt (fortified with folic acid)	2-6 months