Salt-FA to Increase Folate Levels

NCT06174883 | Completed

• 1 other identifier: DFS-1-2022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Folic acid fortified iodized salt DIETARY_SUPPLEMENT

addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hydrocephalus and Neuroscience Institute: lead

Study Sites (1)

Pediatric Neurosurgery

Orlando, Florida, 32827, United States

Location

Related Publications (1)

• Pattisapu JV, Manda VV, Kottakki MNR, Kajana PM, Kancherla V, Bhaganagarapu HR, Veerappan V, Ediga A, Mannar V, Diosady L, Oakley GP Jr. Folic Acid-Fortified Iodized Salt and Serum Folate Levels in Reproductive-Aged Women of Rural India: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241777. doi: 10.1001/jamanetworkopen.2024.1777.

  PMID: 38457177 DERIVED

MeSH Terms

Conditions

Neural Tube Defects; Folic Acid Deficiency; Spinal Dysraphism; Neural tube defects X-linked

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jogi Pattisapu, MD

  Pediatric Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

US (1)