An observational study in Neural Tube Defects, Folic Acid Deficiency and Spina Bifida, sponsored by Hydrocephalus and Neuroscience Institute. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Hydrocephalus and Neuroscience Institute · Observational
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.
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 :
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's enrollment of 80 is below the median of 105 across 48 observational studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Hydrocephalus and Neuroscience Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Spinal Dysraphism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neural Tube Defects. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Women of childbearing age who are non-lactating and willing to consume the study salt for the duration were recruited for voluntary participation into the study.
Inclusion Criteria: • Willing to voluntarily participate in the study
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.
Measure changes in median serum folate levels between baseline and study endpoint
evaluate blood levels pre- and post-intake of study salt (fortified with folic acid)
Time frame: 2-6 months
Plan to share: Undecided — redacted information will be made available upon request.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hydrocephalus and Neuroscience Institute