Using Iodized Salt to Improve Serum Folate, B12 and Iron Levels

NCT06904612 | Completed

• 2 other identifiers: CT06174883191/IEC AMC/MAY 2021
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

Question: How effective is fortified iodized salt in increasing serum concentrations of folate, B12 and iron among non-pregnant and non-lactating women of reproductive age? Hypothesis: Micronutrient fortified iodized salt can increase serum levels (of folate, B12 and iron) and serve as a policy consideration in salt fortification with both iodine and other micronutrients to reduce serious and fatal birth defects.

Conditions

Neural Tube Defects; Folic Acid Deficiency; Spina Bifida; Anencephaly-Spina Bifida; B12 Deficiency Vitamin; Anemia; Iron Deficiency Anaemia Due to Dietary Causes

Keywords

Micronutrient deficiency; Food fortification; dietary salt; India; Folic acid; Neural tube defects; Spina Bifida; anencephaly; anemia; B12 deficiency

Outcome Measures

Primary Outcomes (1)

• Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint

  evaluate blood levels pre- and post-intake of study salt (fortified with folic acid, B12 and iron)

  2-6 months

Interventions

Micronutrient fortified iodized salt DIETARY_SUPPLEMENT

addition of folic acid, B12 and iron to iodized salt to be consumed daily and assess rise in serum levels.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women of childbearing age
• 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 micronutrient supplements 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
• Andhra Medical College: collaborator

Study Sites (2)

Pediatric Neurosurgery

Orlando, Florida, 32827, United States

Location

Andhra Medical College

Visakhapatnam, Andhra Pradesh, 530002, India

Location

MeSH Terms

Conditions

Neural Tube Defects; Folic Acid Deficiency; Spinal Dysraphism; Neural tube defects X-linked; Vitamin B 12 Deficiency; Anemia; Anencephaly

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; Hematologic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Severe Teratoid

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: March 25, 2025
• First Posted: April 1, 2025
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

IN (1); US (1)