Anemia, Anencephaly-Spina Bifida, B12 Deficiency Vitamin, Folic Acid Deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Neural Tube Defects, Spina Bifida
Conditions
Keywords
Micronutrient deficiency, Food fortification, dietary salt, India, Folic acid, Neural tube defects, Spina Bifida, anencephaly, anemia, B12 deficiency
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.
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.
Interventions
DIETARY_SUPPLEMENTMicronutrient fortified iodized salt
addition of folic acid, B12 and iron to iodized salt to be consumed daily and assess rise in serum levels.
Sponsors
Andhra Medical College
Hydrocephalus and Neuroscience Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint | 2-6 months | evaluate blood levels pre- and post-intake of study salt (fortified with folic acid, B12 and iron) |
Countries
India, United States
Outcome results
None listed