NCT06904612

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Hydrocephalus and Neuroscience Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Micronutrient fortified iodized salt	addition of folic acid, B12 and iron to iodized salt to be consumed daily and assess rise in serum levels.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2025-04-01
• Last updated: 2025-07-14

Locations

2 sites across 2 countries: United States, India