Cobalamin DeficiencyNCT02679833
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status
A study testing Cyanocobalamin in people with Cobalamin Deficiency, run by Universität des Saarlandes at 2 sites in Germany.
Trial summary
A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cobalamin Deficiency
- What is being tested?
- Cyanocobalamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults: men and women
- Stable diet for at least 24 months (omnivorous or a vegan diet).
Who cannot join
- Pregnancy and lactation
- Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)
- Renal diseases
- Liver diseases
- Patients with cancer (or cancer history)
- Pre-study treatment with vitamin B12 or folate
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Institute of Alternative and Sustainable Nutrition
Giessen, 35444
University of Saarland
Homburg, Saarland, 66421
About this study
Official title: Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study
A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.
- Conditions
- Cobalamin Deficiency
- Being tested
- Placebo, Cyanocobalamin
- Keywords
- Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid
- Medical subject headings
- Vitamin B 12 Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Toothpaste not containing the vitamin.
CyanocobalaminDietary supplement
Toothpaste containing100 µg cyanocobalamin/g.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12. Receives: Dietary Supplement: Placebo |
| Cyanocobalamin | Active comparator | A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g. Receives: Dietary Supplement: Cyanocobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in plasma concentrations of methylmalonic acid
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
Measured: Baseline, 3 months
The change in plasma concentrations of holotranscobalamin
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
Measured: Baseline, 3 months
The change in plasma concentrations of homocysteine
Lowering homocysteine in the B12 arm compared with the placebo arm
Measured: Baseline, 3 months
The change in plasma concentrations of vitamin B12
The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cobalamin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Alternative and Sustainable Nutrition (IFANE)
- Responsible party
- Principal investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Markus Keller, PhD, Study chair, Institute of Alternative and Sustainable Nutrition, Giessen, GermanyRima Obeid, PhD, Study director, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679833
- Sponsor's protocol ID
- B12 status after toothpaste
- Status last verified
- May 2018
- First submitted
- 8 Feb 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.
Publications
Zant A, Awwad HM, Geisel J, Keller M, Obeid R. Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study. Aging Clin Exp Res. 2019 Dec;31(12):1817-1825. doi: 10.1007/s40520-019-01125-6. Epub 2019 Jan 24.
PubMed 30680547Siebert AK, Obeid R, Weder S, Awwad HM, Sputtek A, Geisel J, Keller M. Vitamin B-12-fortified toothpaste improves vitamin status in vegans: a 12-wk randomized placebo-controlled study. Am J Clin Nutr. 2017 Mar;105(3):618-625. doi: 10.3945/ajcn.116.141978. Epub 2017 Jan 4.
PubMed 28052884
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT02679833
- Acronym / sponsor ID
- B12 status after toothpaste
- Conditions
- Cobalamin Deficiency
- Keywords
- Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- Institute of Alternative and Sustainable Nutrition (IFANE)
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12. |
| Cyanocobalamin | Active comparator | Dietary Supplement: CyanocobalaminA toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults: men and women
- Stable diet for at least 24 months (omnivorous or a vegan diet).
Key exclusion criteria (6 listed)
- Pregnancy and lactation
- Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)
- Renal diseases
- Liver diseases
- Patients with cancer (or cancer history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboToothpaste not containing the vitamin. | Dietary supplement | Placebo |
| CyanocobalaminToothpaste containing100 µg cyanocobalamin/g. | Dietary supplement | Cyanocobalamin |
Primary outcome
The change in plasma concentrations of methylmalonic acid
Time frame: Baseline, 3 months
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
The change in plasma concentrations of holotranscobalamin
Time frame: Baseline, 3 months
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
The change in plasma concentrations of homocysteine
Time frame: Baseline, 3 months
Lowering homocysteine in the B12 arm compared with the placebo arm
The change in plasma concentrations of vitamin B12
Time frame: Baseline, 3 months
The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 30680547Zant A, Awwad HM, Geisel J, Keller M, Obeid R. Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study. Aging Clin Exp Res. 2019 Dec;31(12):1817-1825. doi: 10.1007/s40520-019-01125-6. Epub 2019 Jan 24.
- Derived from this study: PubMed 28052884Siebert AK, Obeid R, Weder S, Awwad HM, Sputtek A, Geisel J, Keller M. Vitamin B-12-fortified toothpaste improves vitamin status in vegans: a 12-wk randomized placebo-controlled study. Am J Clin Nutr. 2017 Mar;105(3):618-625. doi: 10.3945/ajcn.116.141978. Epub 2017 Jan 4.
- Individual participant dataSharing planned: No. Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.
Related trials for Cobalamin Deficiency
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingPhase 2/3
Vitamin B12 Supplementation During Pregnancy on Cognitive Development
Pregnancy Related, Vitamin B 12 Deficiency
Active, not recruitingPhase 1
Vitamin B12 Dose Escalation Trial in Pregnancy
Vitamin B 12 Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Keller, PhD study chair
Institute of Alternative and Sustainable Nutrition, Giessen, Germany
Rima Obeid, PhD study director
Saarland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanocobalamin in people with Cobalamin Deficiency, run by Universität des Saarlandes at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in plasma concentrations of methylmalonic acid (time frame: Baseline, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679833, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.