Viewing Study NCT04731948



Ignite Creation Date: 2024-05-06 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 1:55 PM
Study NCT ID: NCT04731948
Status: COMPLETED
Last Update Posted: 2021-02-01
First Post: 2021-01-26

Brief Title: Vitamin B12 Biomarker Responses to Supplementation
Sponsor: University of Ulster
Organization: University of Ulster

Study Overview

Official Title: A Dose-finding Randomized Trial of Vitamin B12 Supplementation Biomarker Responses and Implications for Dietary Recommendations
Status: COMPLETED
Status Verified Date: 2021-01
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: The aim of the study is to investigate the response of recognized biomarkers of vitamin B12 status to intervention with supplemental vitamin B12 at doses within and beyond the range of typical dietary intakes in younger and older adults

Study design A double-blind randomized controlled trial in healthy adults aged 18 years and over will be conducted Apparently healthy individuals will be recruited from the staff and student population at Ulster University Coleraine and the surrounding local community Those interested in the study will provide informed consent Individuals suffering from chronic conditions those taking medications interfering with folate or vitamin B12 metabolism or B vitamin supplements and women who are pregnant will be excluded from participation Potential participants will provide a non-fasting blood sample and those with plasma creatinine concentration 130 µmolL those with hypochlorhydria diagnosed serologically by pepsinogen I to Pepsinogen II ratio 3 and those with the 677CT polymorphism in the methylenetetrahydrofolate reductase MTHFR gene will also be excluded from the study In addition participants aged 60 years and over who score 25 on the Folsteins Mini-Mental State Examination a cognitive function screening test will be excluded to reduce the risk of including participants with impaired cognitive function and thus reduced ability to comply with the study requirements including compliance with the intervention trial and recall of food intake

All eligible participants will undergo a pre-treatment phase with 400 µgday folic acid FA for 11 weeks At the end of this phase participants will provide a non-fasting blood sample baseline sample and will be stratified within each age category 60 years and 60 years according to their homocysteine concentrations and subsequently randomized from each stratum in a 1111 allocation ratio to one of the four treatments for 16 weeks 400 µgday FA placebo 400 µgday FA 2 µgday vitamin B12 400 µgday FA 10 µgday vitamin B12 or 400 µgday FA 50 µgday vitamin B12 A non-fasting blood sample will be collected at the end of the intervention Biomarkers of vitamin B12 and folate will be measured in blood samples collected at baseline and post-intervention The intervention will be conducted on a staggered basis and both study participants and researchers will be blinded to the treatment allocations Dietary intake of participants will be assessed using a four-day food diary based on 2 weekday and 2 weekend day intakes in combination with a food frequency questionnaire particularly focused on intakes of foods fortified with vitamin B12 and FA
Detailed Description: Detailed Description

The aim of this study is to investigate the response of recognized vitamin B12 biomarkers serum total vitamin B12 serum holotranscobalamin plasma methylmalonic acid plasma homocysteine to intervention with supplemental vitamin B12 at doses within and beyond the range of typical dietary intakes in younger and older adults

The sample size will be estimated by using typical variances from published studies on plasma homocysteine responses to vitamin B12 supplementation in adults The calculations are based on changes in plasma homocysteine as it is considered a functional indicator of vitamin B12 status The typical standard deviation of change will be set at 2µmolL Clarke et al 1998 McKinley et al 2002 with the minimal detectable difference being 15µmolL at 80 power and a significance level of 5 Calculations determined that 40 subjects would be required for each of the three treatment groups plus placebo in order to show significant differences in plasma homocysteine concentrations

Participants will be recruited by posters advertisement emails and organized meetings to promote the study among staff and students at Ulster University Coleraine workplaces social and sporting clubs and sheltered accommodation for older adults in the surrounding local community Those interested in the study will receive a participant information sheet and further details about the study A signed informed consent will be obtained from all who are willing to participate in the study A screening questionnaire and a non-fasting blood sample will be taken to identify those eligible to take part in the study Exclusion criteria will be history of gastrointestinal hepatic renal vascular or haematological diseases or diabetes those taking medications that interfere with folate or vitamin B12 metabolism eg methotrexate proton pump inhibitor drugs use of B vitamin supplements pregnancy plasma creatinine concentration 130 µmolL those with hypochlorhydria diagnosed serologically by pepsinogen I to Pepsinogen II ratio 3 those individuals with the 677CT polymorphism in the MTHFR gene and those aged 60 years and over who scored 25 on Folsteins Mini-Mental State Examination a cognitive function screening test

All eligible participants will undergo a pre-treatment phase with 400 µgday folic acid FA for 11 weeks the treatment with FA will continue until the end of the trial At the end of the pre-treatment phase participants will provide a non-fasting blood sample baseline sample and will be stratified within each age category 60 years and 60 years according to their homocysteine concentrations and subsequently randomized in a 1111 allocation ratio to one of the four treatments for 16 weeks 400 µgday FA placebo 400 µgday FA 2 µgday vitamin B12 400 µgday FA 10 µgday vitamin B12 or 400 µgday FA 50 µgday vitamin B12 A non-fasting blood sample will be collected at the end of the intervention Blood samples at baseline and post-intervention will be analyzed for biomarkers of folate and vitamin B12 status In order to encourage maximal compliance participants will be contacted regularly and provided with supplements in 7-day pillboxes every 4 weeks during the pre-treatment phase and the intervention and will be asked to return the used pillboxes the number of unused capsules will be recorded to monitor compliance The intervention will be conducted on a staggered basis and both study participants and researchers will be blind to treatment allocations Dietary intake of participants will be assessed using a four-day food diary based on 2 weekday and 2 weekend day intakes and a food frequency questionnaire regarding specific intake of foods fortified with vitamin B12 and FA

Anthropometric measurements as height and weight for each participant will be taken by using portable approved scales

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