Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235573
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-10-06
Brief Title:
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vitamin B12 is an essential nutrient that the body needs for cells to divide and function normally Individuals may develop a deficiency of vitamin B12 by either limiting the amount in the diet or by decreased vitamin B12 intake into the body absorption Keeping adequate B12 blood levels is important for health Vitamin B12 deficiency may increase ones risk for developing anemia and can even lead to neurological problems and paralysis if the deficiency is severe and lasts a long time It is very important for doctors to have accurate tests to determine if people are absorbing vitamin B12 normally so that treatment can be started before severe clinical problems occur
The purpose of this research is to provide new information that may help scientists develop a better method to test for problems with absorbing vitamin B12 In this study changes in the amounts of vitamin B12 bound to protein transcobalamin in the blood will be measured after doses of vitamin B12 are taken If the amounts of this vitamin B12-protein complex called holo-transcobalamin change in response to taking a vitamin B12 supplement in normal individuals it may be possible to use this information to develop a new sensitive test to identify individuals who have problems absorbing vitamin B12 This new vitamin B12 absorption test may be a better clinical test for vitamin B12 absorption than those now available for doctors to use
The purpose of this research is to provide new information that may help scientists develop a better method to test for problems with absorbing vitamin B12 In this study changes in the amounts of vitamin B12 bound to protein transcobalamin in the blood will be measured after doses of vitamin B12 are taken If the amounts of this vitamin B12-protein complex called holo-transcobalamin change in response to taking a vitamin B12 supplement in normal individuals it may be possible to use this information to develop a new sensitive test to identify individuals who have problems absorbing vitamin B12 This new vitamin B12 absorption test may be a better clinical test for vitamin B12 absorption than those now available for doctors to use
Detailed Description:
Part I Screening Individuals who meet initial screening criteria will be scheduled to have fasting blood samples drawn in the General Clinical Research Center GCRC All participants will sign informed consent forms approved by the UF Institutional Review Board prior to the initiation of this part of the study Subjects heights and weights will be measured and subjects will be asked to complete a medical history questionnaire Blood analyses will include serum B12 blood chemistry and hematological indices Females will be given a pregnancy test Subjects eligible for Part II of the study Intervention will have serum B12 concentrations that are 444 pmolL will be non-anemic and will have normal general blood chemistry all values within or near the normal range and no history of chronic disease eg pernicious anemia cancer diabetes renal disease hypertension neurological abnormalities gastrointestinal disorders Any subject with deficient 148 pmolL serum B12 concentration 18 will not be eligible for participation and will be instructed to see their personal physician for complete follow-up and treatment
Part II Intervention Changes in B12 status assessment indicators in response to B12 supplementation will be evaluated
Subjects will come to the GCRC the night before Day 1 the intervention protocol The next morning Day 1 following an overnight fast an indwelling catheter will be inserted from which repeated blood samples will be drawn throughout Day 1 A baseline fasting blood sample 1 will be drawn Subjects will then consume a light breakfast including 1 piece of bread and 8 oz of orange juice and will take a 9 ug dose of B12 Dose 1 Thirty minutes after completion of the meal and consumption of the B12 supplement a second blood sample 2 will be drawn Five subsequent hourly blood samples 3-7 will be drawn After the 7th blood sample the subjects will consume one piece of bread and 8 ounces of orange juice and will take a second 9 ug dose of B12 Dose 2 and have a blood sample 8 drawn 30 minutes after consumption of the meal and the B12 dose Five subsequent hourly blood samples 9-13 will be drawn The subjects will then consume one piece of bread and 8 ounces of orange juice and take a 9 ug dose of B12 Dose 3 Another blood sample 14 will be drawn 30 minutes after the meal and the B12 dose One hour later a final Day 1 blood sample 15 will be drawn followed by removal of the catheter In addition to the bread and juice consumed with each B12 supplement subjects will receive a mid-morning snack 2 hours after Dose 1 of the B12 supplement lunch 35 hrs after Dose 1 of the B12 supplement dinner at 4 hours after Dose 2 of the B12 supplement and an evening snack at 3 hours after Dose 3 Low B12-containing foods will be provided in the GCRC Water and non-caffeinated non-caloric beverages will be allowed ad libitum
The subjects will remain in the GCRC overnight and a fasting blood sample 16 will be drawn in the morning on Day 2 On Day 2 participants will be provided breakfast following the blood draw after which they will be free to leave the GCRC Subjects will be provided with take-away meals and snacks lunch dinner snacks consisting of low-B12 containing foods
Subjects will be instructed to return on the morning of Day 3 at which time they will have one am fasting blood sample 17 drawn and will be provided with breakfast before they leave the GCRC All overnight fasts will be from 10 pm the previous night The following B12 indicators will be measured at each blood draw a holo-TC b total-TC c holo-HC and total HC d serum B12 and e plasma albumin Additional B12 status indicators eg homocysteine methylmalonic acid RBC B12 will be measured at select blood draw intervals A baseline folate analysis will be done
Part II Intervention Changes in B12 status assessment indicators in response to B12 supplementation will be evaluated
Subjects will come to the GCRC the night before Day 1 the intervention protocol The next morning Day 1 following an overnight fast an indwelling catheter will be inserted from which repeated blood samples will be drawn throughout Day 1 A baseline fasting blood sample 1 will be drawn Subjects will then consume a light breakfast including 1 piece of bread and 8 oz of orange juice and will take a 9 ug dose of B12 Dose 1 Thirty minutes after completion of the meal and consumption of the B12 supplement a second blood sample 2 will be drawn Five subsequent hourly blood samples 3-7 will be drawn After the 7th blood sample the subjects will consume one piece of bread and 8 ounces of orange juice and will take a second 9 ug dose of B12 Dose 2 and have a blood sample 8 drawn 30 minutes after consumption of the meal and the B12 dose Five subsequent hourly blood samples 9-13 will be drawn The subjects will then consume one piece of bread and 8 ounces of orange juice and take a 9 ug dose of B12 Dose 3 Another blood sample 14 will be drawn 30 minutes after the meal and the B12 dose One hour later a final Day 1 blood sample 15 will be drawn followed by removal of the catheter In addition to the bread and juice consumed with each B12 supplement subjects will receive a mid-morning snack 2 hours after Dose 1 of the B12 supplement lunch 35 hrs after Dose 1 of the B12 supplement dinner at 4 hours after Dose 2 of the B12 supplement and an evening snack at 3 hours after Dose 3 Low B12-containing foods will be provided in the GCRC Water and non-caffeinated non-caloric beverages will be allowed ad libitum
The subjects will remain in the GCRC overnight and a fasting blood sample 16 will be drawn in the morning on Day 2 On Day 2 participants will be provided breakfast following the blood draw after which they will be free to leave the GCRC Subjects will be provided with take-away meals and snacks lunch dinner snacks consisting of low-B12 containing foods
Subjects will be instructed to return on the morning of Day 3 at which time they will have one am fasting blood sample 17 drawn and will be provided with breakfast before they leave the GCRC All overnight fasts will be from 10 pm the previous night The following B12 indicators will be measured at each blood draw a holo-TC b total-TC c holo-HC and total HC d serum B12 and e plasma albumin Additional B12 status indicators eg homocysteine methylmalonic acid RBC B12 will be measured at select blood draw intervals A baseline folate analysis will be done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000082 | NIH | UF Clinical Research Center | httpsreporternihgovquickSearchM01RR000082 |
| 7591 | OTHER_GRANT | None | None |