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Trial record 1 of 1 for:    "Vitamin B12 Deficiency" | "retinol"
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Vitamin Deficiencies and Suppletion in Morbid Obesity

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ClinicalTrials.gov Identifier: NCT02270749
Recruitment Status : Unknown
Verified May 2015 by Rijnstate Hospital.
Recruitment status was:  Recruiting
First Posted : October 21, 2014
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

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.

Condition or disease Intervention/treatment Phase
Vitamin B12 Deficiency Drug: Hydroxocobalamin Drug: FitForMe vitamin B12 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin Deficiencies and Suppletion in Morbid Obesity
Study Start Date : October 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Active Comparator: hydroxocobalamin injection
25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
Drug: Hydroxocobalamin
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.

Active Comparator: FitForMe vitamin B12 tablets
25 patients receive a daily dose vitamine B12 tablets
Drug: FitForMe vitamin B12
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 Measures :
  1. reduction in patients with vitamin B12 deficiency [ Time Frame: 6 months after initiating therapy ]
    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.



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Ages Eligible for Study:   18 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270749


Locations
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Netherlands
Rijnstate hospital Recruiting
Arnhem, Netherlands, 6800WC
Contact: Wendy Schijns, MD    0031880057353    wschijns@rijnstate.nl   
Principal Investigator: Frits Berends, MD PhD         
Sub-Investigator: Wendy Schijns, MD         
Sponsors and Collaborators
Rijnstate Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02270749     History of Changes
Other Study ID Numbers: VITAALII
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Vitamin B 12 Deficiency
Obesity, Morbid
Avitaminosis
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vitamin B Deficiency
Deficiency Diseases
Malnutrition
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics