Assessing the relationship between the dose of vitamin B12 administered and its absorption in the intestine in normal humans

Not yet recruiting

Conditions: During screening,Complete Blood Count , plasma total B12 and Holo-TC concentration will be tested in blood and volunteers with clinical deficiency of vitamin B12 will be excluded from the study.

Registration Number: CTRI/2022/06/043417

Lead Sponsor: Clinical Research Centre Department of Physiology

Brief Summary: This is a randomised crossover study assessing the dose dependency of vitamin B12 on its intestinal absorption in normal individuals. Each participant will receive 3 doses of B12 ,i.e, 2.5, 5 and 10mcg on 3 different days separated by a washout period of 10 days between each dose to ensure the plasma enrichment of B12 reaches pre-dosage level. The primary objective of the study is to determine the absorption of B12 at the three different intake doses . The secondary objective is to investigate the relationship between plasma B12 concentrationat screening and the absorption of B12 at the normal daily intakedose of 2.5 Âµg. Post dosing blood samples will be collected at 1st hour followed by hourly collection from 5 to 7 hours. Blood samples will be analysed within 96 hours. Correlation between amount of B12 dose ingested and its bioavailability will be established.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 9

Inclusion Criteria

1.Apparently healthy participants between the ages of 18 and 40.
2.BMI <25 3.Normal plasma total B12 level 4.Normal active B12 or Holo-TC concentration.

Exclusion Criteria

1.Participants with existing vitamin B12 deficiency 2.Participants with folate deficiency on clinical supplementation 3.Participants with end-stage renal disease or on haemodialysis, atrophic gastritis, history of alcoholism, use of drugs (methotrexate, antacids, and metformin) known to affect B12 absorption, and on antibiotics/medication known to influence GI motility.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin B12 bioavailability	7 hours after administration of Vitamin B12 dose

Secondary Outcome Measures

Name	Time	Method
Decrease in the bioavailability of vitamin B12 with increase in dose administered(2.5 , 5 and 10 mcg)	7 hours after administration of vitamin B12 dose

Trial Locations

Locations (1): Metabolic Lab, St. Johns Medical College
🇮🇳
Bangalore, KARNATAKA, India
Metabolic Lab, St. Johns Medical College
🇮🇳Bangalore, KARNATAKA, India
Poorvikha S
Principal investigator
08049466349
poorvikha.s@stjohns.in