Salt-FA to Increase Folate Levels

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

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.

Study Overview

• Status: Completed
• Conditions: Folic Acid Deficiency; Neural Tube Defects; Spina Bifida; Anencephaly-Spina Bifida
• Intervention / Treatment: Dietary supplement: Folic acid fortified iodized salt

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Pediatric Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hydrocephalus and Neuroscience Institute
• Investigators: Principal Investigator: Jogi Pattisapu, MD, Pediatric Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nervous System Malformations; Vitamin B Deficiency; Abnormalities, Severe Teratoid; Folic Acid Deficiency; Neural Tube Defects; Spinal Dysraphism; Anencephaly; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: DFS-1-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: redacted information will be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No