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OpenTrials
Completed

NCT Number: NCT06904612

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

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.

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Key information

About this study

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 :

  • 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.
  • To assess acceptance of study salt for daily use during 3 months of consumption.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2-6 months

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

Sponsors and collaborators

Lead sponsor

Hydrocephalus and Neuroscience Institute

Other

Collaborators

  • Andhra Medical College

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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