NCT01050556

Brief Summary

The purpose of this study is to determine whether folic acid, alone or together with creatine supplementation, can lower blood arsenic concentrations and improve the ability to detoxify arsenic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

January 13, 2010

Last Update Submit

July 31, 2012

Conditions

High Blood Arsenic Due to Chronic Arsenic Exposure

Keywords

arsenicfolatefolic acidcreatinearsenicosisnutrition

Outcome Measures

Primary Outcomes (1)

  • blood arsenic concentrations

    24 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo daily

Other: Placebo

Folic Acid 400 ug

EXPERIMENTAL

400 µg folic acid daily

Dietary Supplement: folic acid

Folic Acid 800 ug

EXPERIMENTAL

800 µg folic acid daily

Dietary Supplement: folic acid

Creatine

EXPERIMENTAL

creatine daily

Dietary Supplement: creatine

Creatine + Folic Acid

EXPERIMENTAL

creatine + folic acid daily

Dietary Supplement: creatine + folic acid

Interventions

PlaceboOTHER

daily, 24 weeks

Placebo
folic acidDIETARY_SUPPLEMENT

400 ug/d for 12 or 24 weeks

Folic Acid 400 ug
creatineDIETARY_SUPPLEMENT

3 mg/d for 12 weeks

Creatine
creatine + folic acidDIETARY_SUPPLEMENT

3 mg creatine/d + 400 µg folic acid/d for 12 weeks

Creatine + Folic Acid

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently exposed to arsenic via contaminated drinking water
  • Well water arsenic concentration \> 10 ug/L
  • Between the ages of 20 and 65

You may not qualify if:

  • Women who are currently pregnant or plan to become pregnant within the next 6 months
  • Currently taking nutritional supplements
  • Known renal disease
  • Participation in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Arsenic Research Project

Dhaka, Bangladesh

Location

Related Publications (8)

  • Li W, Wu H, Goldsmith J, Glabonjat RA, Ilievski V, Balac O, Slavkovich V, Pinto-Pacheco B, Lin X, Parvez F, Jackson GL, Siddique AB, Uddin MN, Islam T, Martinez-Morata I, Navas-Acien A, Niedzwiecki MM, Kioumourtzoglou MA, Pierce BL, Graziano JH, Bottiglieri T, Walker DI, Gamble MV. Metabolic Signature of Arsenic Exposure and Metabolism: The Folic Acid and Creatine Trial. Environ Sci Technol. 2025 Jul 29;59(29):14905-14916. doi: 10.1021/acs.est.5c01597. Epub 2025 Jul 16.

    PMID: 40668877DERIVED

  • Martinez-Morata I, Wu H, Galvez-Fernandez M, Ilievski V, Bottiglieri T, Niedzwiecki MM, Goldsmith J, Jones DP, Kioumourtzoglou MA, Pierce B, Walker DI, Gamble MV. Metabolomic Effects of Folic Acid Supplementation in Adults: Evidence from the FACT Trial. J Nutr. 2024 Feb;154(2):670-679. doi: 10.1016/j.tjnut.2023.12.010. Epub 2023 Dec 12.

    PMID: 38092151DERIVED

  • Abuawad AK, Bozack AK, Navas-Acien A, Goldsmith J, Liu X, Hall MN, Ilievski V, Lomax-Luu AM, Parvez F, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. The Folic Acid and Creatine Trial: Treatment Effects of Supplementation on Arsenic Methylation Indices and Metabolite Concentrations in Blood in a Bangladeshi Population. Environ Health Perspect. 2023 Mar;131(3):37015. doi: 10.1289/EHP11270. Epub 2023 Mar 28.

    PMID: 36976258DERIVED

  • 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.

    PMID: 34661903DERIVED

  • Bozack AK, Howe CG, Hall MN, Liu X, Slavkovich V, Ilievski V, Lomax-Luu AM, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. Betaine and choline status modify the effects of folic acid and creatine supplementation on arsenic methylation in a randomized controlled trial of Bangladeshi adults. Eur J Nutr. 2021 Jun;60(4):1921-1934. doi: 10.1007/s00394-020-02377-z. Epub 2020 Sep 11.

    PMID: 32918135DERIVED

  • Bozack AK, Hall MN, Liu X, Ilievski V, Lomax-Luu AM, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. Folic acid supplementation enhances arsenic methylation: results from a folic acid and creatine supplementation randomized controlled trial in Bangladesh. Am J Clin Nutr. 2019 Feb 1;109(2):380-391. doi: 10.1093/ajcn/nqy148.

    PMID: 30590411DERIVED

  • Hall MN, Howe CG, Liu X, Caudill MA, Malysheva O, Ilievski V, Lomax-Luu AM, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Graziano JH, Gamble MV. Supplementation with Folic Acid, but Not Creatine, Increases Plasma Betaine, Decreases Plasma Dimethylglycine, and Prevents a Decrease in Plasma Choline in Arsenic-Exposed Bangladeshi Adults. J Nutr. 2016 May;146(5):1062-7. doi: 10.3945/jn.115.227132. Epub 2016 Apr 6.

    PMID: 27052531DERIVED

  • Peters BA, Hall MN, Liu X, Parvez F, Siddique AB, Shahriar H, Uddin MN, Islam T, Ilievski V, Graziano JH, Gamble MV. Low-Dose Creatine Supplementation Lowers Plasma Guanidinoacetate, but Not Plasma Homocysteine, in a Double-Blind, Randomized, Placebo-Controlled Trial. J Nutr. 2015 Oct;145(10):2245-52. doi: 10.3945/jn.115.216739. Epub 2015 Aug 26.

    PMID: 26311810DERIVED

MeSH Terms

Interventions

Folic AcidCreatine

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mary V Gamble, PhD

    Columbia University, Department of Environmental Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Environmental Health Sciences

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

BA(1)