Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708704
Status:
WITHDRAWN
Last Update Posted:
2022-11-01
First Post:
2020-12-21
Brief Title:
Photodegraded Edible Food Dyes
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Investigation of Photodegraded Edible Food Dyes in Drinking Water on Thyroid Function
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not able to start the study due to COVID
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assess and contrast the effect of erythrosine and photodegraded erythrosine on thyroid function Thyroid function will be evaluated as serum triiodothyronine T3 thyroxine T4 thyroid stimulating hormone TSH T3 resin uptake as well as measures of iodine in serum and plasma before and after a 14-day repeat administration of these edible dyes in drinking water Dose-related increases in serum and plasma-bound iodine are expected for both erythrosine and photodegraded erythrosine over the 14-day exposure period TSH is also expected to increase following repeat administration of erythrosine and photodegraded erythrosine Erythrosine and photodegraded erythrosine are expected to induce an equivalent dose-response increase in thyroid function-related hormone levels
Detailed Description:
Access to safe drinking water is a fundamental human right recognized by the United Nations yet achieving universal access in the developing world has been impeded by insufficient water treatment infrastructure and lack of sustained maintenance As of 2015 844 million individuals in low- and lower-middle-income countries LMICs did not have access to improved drinking water sources and 159 million people directly used untreated surface water resulting in the loss of 502 thousand lives annually by diarrheal diseases from pathogen-contaminated water Because drinking water inequity and the associated mortality disproportionally burden the rural developing world the provision of improved point-of-use POU water treatment technologies that are low cost simple and require minimal infrastructure is crucial for achieving ubiquitous access to safe drinking water
Several POU water treatment methods are currently applied in LMICs eg solar disinfection SODIS granular media or ceramic pot filtration chlorination etc Although effective against bacteria most perform relatively poorly for virus removal and all POU technologies demonstrate lower efficacy in the field due to compromised initial water quality and operation by relatively unskilled users While POU technologies have contributed to the reduction of bacterial and parasitic gastroenteritis instances of viral gastroenteritis have not declined with viral agents observed in 43 of developing world diarrheal cases
One POU technology in development that has demonstrated potential for inactivating viruses in drinking water is the application of an edible photosensitizing dye to the water for disinfection When exposed to sunlight the photosensitizing dye produces singlet oxygen a reactive oxygen species ROS capable of inactivating a wide range of viruses Erythrosine an FDA-approved dye has proven its ability to disinfect drinking water achieving 4-log inactivation of bacteriophage MS2 in under 10 minutes of sunlight exposure Furthermore the dye photobleaches upon exposure to light and the accompanying distinct color change eg from erythrosine red to transparent occurs at a rate comparable to the disinfection providing a safety indication that disinfection has completed a much-needed function lacking in other POU technologies At a total cost of 0002-0003 per liter of treated water it is cheaper than boiling water in several developing nations and is a financially viable water disinfection technology
Erythrosine also known as FDC Red No 3 in the USA is approved by the FDA for use in foods drugs and cosmetics with an acceptable daily intake ADI of 25 mgkg bwday The concentration recommended by literature for disinfection in drinking water is 50 µM erythrosine or approximately 44 mgL With the average American consuming 238 L of drinking water and beverages per day a daily exposure of 105 mg erythrosineday is expected Assuming the total water consumption per day in LMICs matches the American consumption of 238 L then a 60-kg individual would experience a daily erythrosine dose of 017 mgkg bwday well below the established FDA ADI
The motivation for investigating the human health effects of erythrosine stems from the unknown behavior of the photodegradation products While the molecular structure of erythrosine will change upon oxidation by singlet oxygen the typical reactions of singlet oxygen are addition reactions that do not typically lead to cleavage of the molecular structure As a result it is not expected that the absorption rates of erythrosine to change significantly upon oxidative photobleaching However these oxidative products have not been previously tested for toxicity and should be examined before allowing erythrosine-based water disinfection to be further developed Recent tests have attempted to characterize the photooxidation products of erythrosine but were inconclusive
Furthermore previous literature states that 19 of iodine in the molecular structure of erythrosine is released to the solution after exposure to light and oxidation by singlet oxygen If the previous water treatment parameters are followed 50 µM erythrosine 238 L waterday 60 kg individual the daily consumption of iodine released from erythrosine would be 11 mg Iday The lowest observed adverse effect level LOAEL and no-observed adverse effect level NOAEL for iodine are 17 mg Iday and 10-12 mg Iday resulting in the tolerable upper intake level UL of 11 mg Iday If the literature-reported release of iodine from erythrosine is correct then exposures are at the UL for iodine Due to the poor absorption of erythrosine by the gastrointestinal tract it is not expected that the iodine which remains bound to erythrosine to significantly impact the total iodine consumption While it is not expected that erythrosine-based water treatment to result in adverse outcomes due to exposure to erythrosine photoproducts or overexposure to iodine it is important to follow a cautious approach and test for its impact before allowing for the further development of a technology that would be consumed daily by individuals in the developing world
Several POU water treatment methods are currently applied in LMICs eg solar disinfection SODIS granular media or ceramic pot filtration chlorination etc Although effective against bacteria most perform relatively poorly for virus removal and all POU technologies demonstrate lower efficacy in the field due to compromised initial water quality and operation by relatively unskilled users While POU technologies have contributed to the reduction of bacterial and parasitic gastroenteritis instances of viral gastroenteritis have not declined with viral agents observed in 43 of developing world diarrheal cases
One POU technology in development that has demonstrated potential for inactivating viruses in drinking water is the application of an edible photosensitizing dye to the water for disinfection When exposed to sunlight the photosensitizing dye produces singlet oxygen a reactive oxygen species ROS capable of inactivating a wide range of viruses Erythrosine an FDA-approved dye has proven its ability to disinfect drinking water achieving 4-log inactivation of bacteriophage MS2 in under 10 minutes of sunlight exposure Furthermore the dye photobleaches upon exposure to light and the accompanying distinct color change eg from erythrosine red to transparent occurs at a rate comparable to the disinfection providing a safety indication that disinfection has completed a much-needed function lacking in other POU technologies At a total cost of 0002-0003 per liter of treated water it is cheaper than boiling water in several developing nations and is a financially viable water disinfection technology
Erythrosine also known as FDC Red No 3 in the USA is approved by the FDA for use in foods drugs and cosmetics with an acceptable daily intake ADI of 25 mgkg bwday The concentration recommended by literature for disinfection in drinking water is 50 µM erythrosine or approximately 44 mgL With the average American consuming 238 L of drinking water and beverages per day a daily exposure of 105 mg erythrosineday is expected Assuming the total water consumption per day in LMICs matches the American consumption of 238 L then a 60-kg individual would experience a daily erythrosine dose of 017 mgkg bwday well below the established FDA ADI
The motivation for investigating the human health effects of erythrosine stems from the unknown behavior of the photodegradation products While the molecular structure of erythrosine will change upon oxidation by singlet oxygen the typical reactions of singlet oxygen are addition reactions that do not typically lead to cleavage of the molecular structure As a result it is not expected that the absorption rates of erythrosine to change significantly upon oxidative photobleaching However these oxidative products have not been previously tested for toxicity and should be examined before allowing erythrosine-based water disinfection to be further developed Recent tests have attempted to characterize the photooxidation products of erythrosine but were inconclusive
Furthermore previous literature states that 19 of iodine in the molecular structure of erythrosine is released to the solution after exposure to light and oxidation by singlet oxygen If the previous water treatment parameters are followed 50 µM erythrosine 238 L waterday 60 kg individual the daily consumption of iodine released from erythrosine would be 11 mg Iday The lowest observed adverse effect level LOAEL and no-observed adverse effect level NOAEL for iodine are 17 mg Iday and 10-12 mg Iday resulting in the tolerable upper intake level UL of 11 mg Iday If the literature-reported release of iodine from erythrosine is correct then exposures are at the UL for iodine Due to the poor absorption of erythrosine by the gastrointestinal tract it is not expected that the iodine which remains bound to erythrosine to significantly impact the total iodine consumption While it is not expected that erythrosine-based water treatment to result in adverse outcomes due to exposure to erythrosine photoproducts or overexposure to iodine it is important to follow a cautious approach and test for its impact before allowing for the further development of a technology that would be consumed daily by individuals in the developing world
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None