ClinicalTrials.Veeva

Menu

Folic Acid and Creatine as Therapeutic Approaches for Lowering Blood Arsenic (FACTA)

Columbia University logo

Columbia University

Status and phase

Completed
Phase 4

Conditions

High Blood Arsenic Due to Chronic Arsenic Exposure

Treatments

Other: Placebo
Dietary Supplement: creatine
Dietary Supplement: folic acid
Dietary Supplement: creatine + folic acid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01050556
AAAC8618
R01CA133595 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Approximately 140 million people in over 70 countries are chronically exposed to arsenic (As)-contaminated drinking water at concentrations far exceeding the World Health Organization standard of 10 µg/L. As is a carcinogen known to cause cancers of the skin, bladder, and lung, as well as ischemic heart disease and neurologic impairments. Methylation of ingested inorganic arsenic (InAs) to methylarsonic-(MMA) and dimethylarsinic acids (DMA) relies on folate-dependent one carbon metabolism, utilizing S-adenosylmethionine (SAM) as the methyl donor, and facilitates urinary As elimination. The results from our Nutritional Influences on Arsenic Toxicity (NIAT) study indicate that folate deficiency and hyperhomocysteinemia (HHcys) are associated with a reduced capacity to methylate arsenic and are risk factors for arsenic-induced skin lesions. Furthermore, folic acid (FA) supplementation does indeed facilitate As elimination and significantly lowers blood As concentrations in individuals who are folate deficient. We have also determined that blood As is a good biomarker of As exposure and is directly associated with the risk for As-induced skin lesions. Collectively, the implication of these findings is that FA has enormous therapeutic potential for ameliorating the long-term health consequences of arsenic exposure for the many populations at risk. However, several fundamental questions remain and will be addressed in this study. This trial is designed to determine 1) whether FA supplementation lowers blood As concentrations in the general Bangladeshi population, 2) at what time point a nadir in blood As is achieved, and 3) whether creatine supplementation, alone or in addition to 400 µg/d FA, will spare methyl groups, resulting in lower blood As, lower homocysteine (Hcys) concentrations, and increased methylation of As. The creatine arms are based on multiple studies that show that urinary creatinine concentrations are a very strong predictor of As methylation. The final step in creatine biosynthesis is the methylation of guanidinoacetate to creatine; this process consumes 50-75% of all SAM-derived methyl groups and is also responsible for 50-75% of all Hcys biosynthesis. Thus, this trial will test the hypothesis that creatine supplementation, which shuts down endogenous creatine biosynthesis, will spare methyl groups, lower Hcys, and increase As methylation.

Enrollment

600 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

600 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo daily
Treatment:
Other: Placebo
Folic Acid 400 ug
Experimental group
Description:
400 µg folic acid daily
Treatment:
Dietary Supplement: folic acid
Dietary Supplement: folic acid
Folic Acid 800 ug
Experimental group
Description:
800 µg folic acid daily
Treatment:
Dietary Supplement: folic acid
Dietary Supplement: folic acid
Creatine
Experimental group
Description:
creatine daily
Treatment:
Dietary Supplement: creatine
Creatine + Folic Acid
Experimental group
Description:
creatine + folic acid daily
Treatment:
Dietary Supplement: creatine + folic acid

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems