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

Micronutrient-fortified Iodized Salt and Serum Concentrations of Folate, B12 and Iron in Reproductive-aged Women of Rural India

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Folic Acid Deficiency; Neural Tube Defects; Spina Bifida; B12 Deficiency Vitamin; Iron Deficiency Anaemia Due to Dietary Causes; Anencephaly-Spina Bifida
• Intervention / Treatment: Dietary supplement: Micronutrient 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 and other micronutrients (such as B12 and iron) through this dietary mechanism.

AIM:To assess increase in blood concentrations of folate, B12 and iron among women of reproductive age who consume micronutrient-fortified iodized salt for 3 months.

OBJECTIVES :

1. To examine the effect of consumption of iodized salt fortified with folic acid, B12 and iron on serum/plasma concentrations among women of reproductive age.
2. To assess acceptance of study salt for daily use during 3 months of consumption.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • Andhra Medical College
• 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 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)

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, 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

Collaborators and Investigators

• Sponsor: Hydrocephalus and Neuroscience Institute
• Collaborators: Andhra Medical College
• 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: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: anemia; Folic acid; India; dietary salt; Spina Bifida; Micronutrient deficiency; Food fortification; B12 deficiency; anencephaly; Neural tube defects
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Metabolic Diseases; Hematologic Diseases; Congenital Abnormalities; Nervous System Malformations; Iron Metabolism Disorders; Anemia, Hypochromic; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Abnormalities, Severe Teratoid; Iron Deficiencies; Anemia; Anemia, Iron-Deficiency; Spinal Dysraphism; Vitamin A Deficiency; Avitaminosis; Anencephaly; Neural Tube Defects; Folic Acid Deficiency; Vitamin B 12 Deficiency; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: CT06174883; 191/IEC AMC/MAY 2021 (Other Identifier: Andhra Medical College Institutional Ethics Committee)

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
• product manufactured in and exported from the U.S.: No