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Vitamin Deficiencies and Suppletion in Morbid Obesity

Primary Purpose

Vitamin B12 Deficiency

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Hydroxocobalamin
FitForMe vitamin B12
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin B12 Deficiency

Eligibility Criteria

18 Months - 65 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Vitamin B12 deficiency: <200 pmol/l
  • Vitamin B12 deficiency 6-12 months after surgery
  • All patients underwent a Roux-en-Y gastric bypass

Exclusion Criteria:

  1. Creatin >150micromol/L
  2. Liver enzymes >2 times upper limit
  3. Other bariatric operations
  4. Intercurrent diseases
  5. Gastro-intestinal diseases
  6. Psychiatric disease
  7. Medicines which influences bone density
  8. Pregnancy

Sites / Locations

  • Rijnstate hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

hydroxocobalamin injection

FitForMe vitamin B12 tablets

Arm Description

25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection

25 patients receive a daily dose vitamine B12 tablets

Outcomes

Primary Outcome Measures

reduction in patients with vitamin B12 deficiency
Before starting treatment vitamin B12, homocystein and methylmalonic acid will be measured. Two and 4 months after starting treatment vitamine B12 levels will be measured. At 6 months after initiating therapy again vitamin B12, homocystein and methylmalonic acid will be measured.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2014
Last Updated
June 8, 2020
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02270749
Brief Title
Vitamin Deficiencies and Suppletion in Morbid Obesity
Official Title
Vitamin Deficiencies and Suppletion in Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.
Detailed Description
Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass. Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydroxocobalamin injection
Arm Type
Active Comparator
Arm Description
25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
Arm Title
FitForMe vitamin B12 tablets
Arm Type
Active Comparator
Arm Description
25 patients receive a daily dose vitamine B12 tablets
Intervention Type
Drug
Intervention Name(s)
Hydroxocobalamin
Intervention Description
patients are treated for 6 months with hydroxocobalamin. Patients will be treated with once a dose of 2000ug, after that treatment will be continued with a dose of 1000ug per 2 months. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
Intervention Type
Drug
Intervention Name(s)
FitForMe vitamin B12
Intervention Description
patients are treated for 6 months with a daily dose of 1000ug vitamin B12 tablets. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
Primary Outcome Measure Information:
Title
reduction in patients with vitamin B12 deficiency
Description
Before starting treatment vitamin B12, homocystein and methylmalonic acid will be measured. Two and 4 months after starting treatment vitamine B12 levels will be measured. At 6 months after initiating therapy again vitamin B12, homocystein and methylmalonic acid will be measured.
Time Frame
6 months after initiating therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vitamin B12 deficiency: <200 pmol/l Vitamin B12 deficiency 6-12 months after surgery All patients underwent a Roux-en-Y gastric bypass Exclusion Criteria: Creatin >150micromol/L Liver enzymes >2 times upper limit Other bariatric operations Intercurrent diseases Gastro-intestinal diseases Psychiatric disease Medicines which influences bone density Pregnancy
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
ZIP/Postal Code
6800WC
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29931179
Citation
Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
Results Reference
derived

Learn more about this trial

Vitamin Deficiencies and Suppletion in Morbid Obesity

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