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

Hydrocephalus and Neuroscience Institute

Status: Completed

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

Treatments: Dietary Supplement: Micronutrient fortified iodized salt

Study type: Observational

Funder types: Other

Identifiers

NCT06904612

CT06174883

191/IEC AMC/MAY 2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)