Salt-FA to Increase Folate Levels

Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.

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Key information

Conditions

Neural Tube Defects Anencephaly-Spina Bifida Avitaminosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Folic Acid Deficiency Malnutrition Nervous System Diseases Nervous System Malformations Neural tube defects X-linked Nutrition Disorders Nutritional and Metabolic Diseases Spina Bifida Spinal Dysraphism Vitamin B Deficiency

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Pediatric Neurosurgery

Orlando, Florida, 32827, United States

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 through this dietary mechanism.

AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt.

OBJECTIVES :

To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age.
To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt 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 FA 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

Folic acid fortified iodized salt

Dietary Supplement

addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.

Primary outcomes

Measure changes in median serum folate 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)

Sponsors and collaborators

Lead sponsor

Hydrocephalus and Neuroscience Institute

Other

Registry information

Official study title

Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 18, 2023
Registry last updated: Dec 19, 2023

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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Completed