Arsenic ExposureNCT03384862
Nutrition, Arsenic and Cognitive Function in Children
A study testing Vitamin B12 and Folic Acid in people with Arsenic Exposure, run by Columbia University at 1 site in Bangladesh.
Trial summary
The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Arsenic Exposure
- What is being tested?
- Vitamin B12 and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteBangladesh
- Study dates
- 27 Jan 2018to 9 May 2019
- Phase
- Interventional
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort
Who cannot join
- siblings
- twins
- children who are not attending school
- children with known physical disability or known chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.
Read the detailed description
While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.
- Conditions
- Arsenic Exposure
- Being tested
- Vitamin B12, Placebo, Folic Acid
- Keywords
- Arsenic exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
PlaceboDietary supplement
Placebo pills, with same appearance as intervention pills.
Folic AcidDietary supplement
400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Intervention Arm | Experimental | 5 μg vitamin B12 plus 400 μg folic acid Receives: Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid |
| Control Arm | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arsenic methylation
Change in arsenic methylation patterns in blood and urine. The ability to methylate arsenic influences an individual's ability to excrete it in urine.
Measured: Up to 12 Weeks
Change in in blood arsenic
Change in arsenic level in blood is to be measured in mg/L. This is an indicator of the body burden of arsenic and arsenic excretion
Measured: Up to 12 Weeks
Change in blood monomethyl arsenic
Change in monomethyl arsenic level in blood is to be measured in units of ug/L. This is an indicator of the body burden of arsenic and arsenic methylation capacity.
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start27 Jan 2018
- Primary completion9 May 2019
- Study completion9 May 2019
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 Arsenic ExposureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Mary Gamble, Columbia University
- Investigators
- Mary V Gamble, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384862
- Sponsor's protocol ID
- AAAQ9290
- Other IDs
- 2P42ES010349-16
- Status last verified
- Feb 2021
- First submitted
- 20 Dec 2017
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.
PubMed 34661903
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Arsenic and Cognitive Function in Children
- ClinicalTrials.gov ID
- NCT03384862
- Acronym / sponsor ID
- AAAQ9290
- Conditions
- Arsenic Exposure
- Keywords
- Arsenic exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 27 Jan 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 28 Dec 2017 (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.
The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.
Detailed description
While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Intervention Arm | Experimental | Dietary Supplement: Vitamin B12, Dietary Supplement: Folic Acid5 μg vitamin B12 plus 400 μg folic acid |
| Control Arm | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort
Key exclusion criteria (4 listed)
- siblings
- twins
- children who are not attending school
- children with known physical disability or known chronic illness
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 |
|---|---|---|
| Vitamin B125 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US. | Dietary supplement | Nutritional Intervention Arm |
| PlaceboPlacebo pills, with same appearance as intervention pills. | Dietary supplement | Control Arm |
| Folic Acid400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US. | Dietary supplement | Nutritional Intervention Arm |
Primary outcome
Change in arsenic methylation
Time frame: Up to 12 Weeks
Change in arsenic methylation patterns in blood and urine. The ability to methylate arsenic influences an individual's ability to excrete it in urine.
Change in in blood arsenic
Time frame: Up to 12 Weeks
Change in arsenic level in blood is to be measured in mg/L. This is an indicator of the body burden of arsenic and arsenic excretion
Change in blood monomethyl arsenic
Time frame: Up to 12 Weeks
Change in monomethyl arsenic level in blood is to be measured in units of ug/L. This is an indicator of the body burden of arsenic and arsenic methylation capacity.
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 16 Feb 2021.
- Derived from this study: PubMed 34661903Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Arsenic Exposure
Active, not recruiting
Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire
Arsenic Poisoning, Environmental Exposure
Active, not recruiting
Strong Heart Water Study
Arsenic Poisoning
Enrolling by invitation
Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation
Arsenic and/or Arsenic Compound Adverse Reaction
Enrolling by invitationObservational study
Assessing Toxic Metal Exposure From Vegetarian/Vegan, Omnivorous, and Low-carb Diets in Israel.
Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring
Active, not recruiting
Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water
Pollution; Exposure
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.
Mary V Gamble, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 and Folic Acid in people with Arsenic Exposure, run by Columbia University at 1 site in Bangladesh.
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 1 inclusion and 4 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 16 Feb 2021. 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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?
Change in arsenic methylation (time frame: Up to 12 Weeks). The study lists 3 primary outcomes in all. 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 NCT03384862, 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 16 Feb 2021.