Neural Tube DefectsNCT06174883
Salt-FA to Increase Folate Levels
An observational study of Neural Tube Defects and Folic Acid Deficiency, run by Hydrocephalus and Neuroscience Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects, Folic Acid Deficiency, Spina Bifida
- What is being tested?
- Folic acid fortified iodized salt
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India
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.
Read the 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 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.
- Being tested
- Folic acid fortified iodized salt
- Medical subject headings
- Neural Tube Defects, Folic Acid Deficiency, Spinal Dysraphism, Neural tube defects X-linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid fortified iodized saltDietary supplement
addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hydrocephalus and Neuroscience Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogi Pattisapu, MD, Principal investigator, Pediatric Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174883
- Sponsor's protocol ID
- DFS-1-2022
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: redacted information will be made available upon request.
Publications
Pattisapu JV, Manda VV, Kottakki MNR, Kajana PM, Kancherla V, Bhaganagarapu HR, Veerappan V, Ediga A, Mannar V, Diosady L, Oakley GP Jr. Folic Acid-Fortified Iodized Salt and Serum Folate Levels in Reproductive-Aged Women of Rural India: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241777. doi: 10.1001/jamanetworkopen.2024.1777.
PubMed 38457177
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India
- ClinicalTrials.gov ID
- NCT06174883
- Acronym / sponsor ID
- DFS-1-2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hydrocephalus and Neuroscience InstituteUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acid fortified iodized saltaddition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels. | Dietary supplement | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 38457177Pattisapu JV, Manda VV, Kottakki MNR, Kajana PM, Kancherla V, Bhaganagarapu HR, Veerappan V, Ediga A, Mannar V, Diosady L, Oakley GP Jr. Folic Acid-Fortified Iodized Salt and Serum Folate Levels in Reproductive-Aged Women of Rural India: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241777. doi: 10.1001/jamanetworkopen.2024.1777.
- Individual participant dataSharing planned: Undecided. redacted information will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogi Pattisapu, MD principal investigator
Pediatric Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Tube Defects and Folic Acid Deficiency, run by Hydrocephalus and Neuroscience Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure changes in median serum folate levels between baseline and study endpoint (time frame: 2-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.