Nutritional Supplement ToxicityKnoVIBNCT02586181
Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People (KnoVIB)
A study testing Vitamin D and Calcium and Vitamin D, Calcium, Vitamins B9, B6, B12 in people with Nutritional Supplement Toxicity, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Supplement Toxicity
- What is being tested?
- Vitamin D and Calcium and Vitamin D, Calcium, Vitamins B9, B6, B12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jul 2011
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age> 50 years,
- male and female
Who cannot join
- renal dysfunction,
- recent stroke or coronary event within the last 3 months,
- current cancer,
- antifolate treatment,
- ileum resection,
- existing B vitamins supplementation,
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- megaloblastic anemia,
- osteoporotic patients treated with pharmacological doses of vitamin D or antiosteoporotic drugs.
- Termination criteria were:
- indication for a high-dose vitamin B supplementation,
- coronary or vascular event,
- or surgical procedures during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People
The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.
Read the detailed description
The current study aimed at investigating if homocysteine-lowering effect (low doses of B-vitamins) will add any measurable beneficial effect on bone markers when added to the standard recommendations for prevention of osteoporosis.
- Conditions
- Nutritional Supplement Toxicity
- Being tested
- Vitamin D and Calcium, Vitamin D, Calcium, Vitamins B9, B6, B12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and CalciumDietary supplement
a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
Arm: Experimental: Vitamin D, Calcium, Vitamins B9, B6, B12
1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12
Vitamin D, Calcium, Vitamins B9, B6, B12Dietary supplement
a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and Calcium | Placebo comparator | a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate Receives: Dietary Supplement: Vitamin D and Calcium |
| Vitamin D, Calcium, Vitamins B9, B6, B12 | Experimental | a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12 Receives: Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone formation markers
Concentrations of bone formation markers in plasma [OC (ng/ml), BAP (U/L)]: are measured: if all are increased indicate enhanced bone formation
Measured: baseline, 6 and 12 months
Secondary outcomes (8)
Changes in plasma choline and betaine
plasma choline and betaine (all µmol/L): if both increased indicate saving betaine and choline
Measured: baseline and aftter 12 months
Changes in global DNA methylation
global DNA methylation [line 1-methylation (expressed as %)]
Measured: baseline and after 12 months
Changes in gene-specific gene methylation
After isolating DNA from whole blood, changes in methylation of targeted genes is studied (expressed as %)
Measured: baseline and after 12 months
Changes in TMAO
Plasma concentrations of TMAO ((µmol/L) is measured
Measured: baseline and after 6 and 12 months
Changes in phospholipid concentration in plasma
Plasma phospholipids ((µmol/L) are measured
Measured: baseline and after 12 months
Changes in concentrations of bone resorption markers
concentrations of bone resorption markers [plasma TRAP5b (U/L), urine DPD (nmol//mmol creatinine)]: if both are increased indicate enhanced bone resorption
Measured: baseline, 6 and 12 months
Changes in plasma homocysteine concentrations
changes in plasma homocysteine (µmol/L) between the time points
Measured: baseline, 6 and 12 months
Changes in plasma levels of folate
changes in serum and whole blood folate (nmol/L)
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nutritional Supplement ToxicityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Rima Obeid, PhD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586181
- Sponsor's protocol ID
- Vitamins and bone markers
- Acronym
- KnoVIB
- Status last verified
- Apr 2019
- First submitted
- 21 Oct 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirsch SH, Herrmann W, Kruse V, Eckert R, Graber S, Geisel J, Obeid R. One year B-vitamins increases serum and whole blood folate forms and lowers plasma homocysteine in older Germans. Clin Chem Lab Med. 2015 Feb;53(3):445-52. doi: 10.1515/cclm-2014-0540.
PubMed 25283139Hubner U, Geisel J, Kirsch SH, Kruse V, Bodis M, Klein C, Herrmann W, Obeid R. Effect of 1 year B and D vitamin supplementation on LINE-1 repetitive element methylation in older subjects. Clin Chem Lab Med. 2013 Mar 1;51(3):649-55. doi: 10.1515/cclm-2012-0624.
PubMed 23314556Herrmann W, Kirsch SH, Kruse V, Eckert R, Graber S, Geisel J, Obeid R. One year B and D vitamins supplementation improves metabolic bone markers. Clin Chem Lab Med. 2013 Mar 1;51(3):639-47. doi: 10.1515/cclm-2012-0599.
PubMed 23183751Obeid R, Hubner U, Bodis M, Graeber S, Geisel J. Effect of adding B-vitamins to vitamin D and calcium supplementation on CpG methylation of epigenetic aging markers. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):411-417. doi: 10.1016/j.numecd.2017.12.006. Epub 2017 Dec 29.
PubMed 29395637Obeid R, Awwad HM, Rabagny Y, Graeber S, Herrmann W, Geisel J. Plasma trimethylamine N-oxide concentration is associated with choline, phospholipids, and methyl metabolism. Am J Clin Nutr. 2016 Mar;103(3):703-11. doi: 10.3945/ajcn.115.121269. Epub 2016 Feb 10.
PubMed 26864355
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People
- ClinicalTrials.gov ID
- NCT02586181
- Acronym / sponsor ID
- KnoVIB / Vitamins and bone markers
- Conditions
- Nutritional Supplement Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Oct 2015 (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.
The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.
Detailed description
The current study aimed at investigating if homocysteine-lowering effect (low doses of B-vitamins) will add any measurable beneficial effect on bone markers when added to the standard recommendations for prevention of osteoporosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and Calcium | Placebo comparator | Dietary Supplement: Vitamin D and Calciuma combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate |
| Vitamin D, Calcium, Vitamins B9, B6, B12 | Experimental | Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age> 50 years,
- male and female
Key exclusion criteria (12 listed)
- renal dysfunction,
- recent stroke or coronary event within the last 3 months,
- current cancer,
- antifolate treatment,
- ileum resection,
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 |
|---|---|---|
| Vitamin D and Calciuma combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate Arm: Experimental: Vitamin D, Calcium, Vitamins B9, B6, B12 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12 | Dietary supplement | Vitamin D and Calcium |
| Vitamin D, Calcium, Vitamins B9, B6, B12a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12 | Dietary supplement | Vitamin D, Calcium, Vitamins B9, B6, B12 |
Primary outcome
Changes in bone formation markers
Time frame: baseline, 6 and 12 months
Concentrations of bone formation markers in plasma [OC (ng/ml), BAP (U/L)]: are measured: if all are increased indicate enhanced bone formation
8 secondary outcomes
Changes in plasma choline and betaine
Time frame: baseline and aftter 12 months
Changes in global DNA methylation
Time frame: baseline and after 12 months
Changes in gene-specific gene methylation
Time frame: baseline and after 12 months
Changes in TMAO
Time frame: baseline and after 6 and 12 months
Changes in phospholipid concentration in plasma
Time frame: baseline and after 12 months
Changes in concentrations of bone resorption markers
Time frame: baseline, 6 and 12 months
Changes in plasma homocysteine concentrations
Time frame: baseline, 6 and 12 months
Changes in plasma levels of folate
Time frame: baseline, 6 and 12 months
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 4 Apr 2019.
- Results publication: PubMed 25283139Kirsch SH, Herrmann W, Kruse V, Eckert R, Graber S, Geisel J, Obeid R. One year B-vitamins increases serum and whole blood folate forms and lowers plasma homocysteine in older Germans. Clin Chem Lab Med. 2015 Feb;53(3):445-52. doi: 10.1515/cclm-2014-0540.
- Results publication: PubMed 23314556Hubner U, Geisel J, Kirsch SH, Kruse V, Bodis M, Klein C, Herrmann W, Obeid R. Effect of 1 year B and D vitamin supplementation on LINE-1 repetitive element methylation in older subjects. Clin Chem Lab Med. 2013 Mar 1;51(3):649-55. doi: 10.1515/cclm-2012-0624.
- Results publication: PubMed 23183751Herrmann W, Kirsch SH, Kruse V, Eckert R, Graber S, Geisel J, Obeid R. One year B and D vitamins supplementation improves metabolic bone markers. Clin Chem Lab Med. 2013 Mar 1;51(3):639-47. doi: 10.1515/cclm-2012-0599.
- Derived from this study: PubMed 29395637Obeid R, Hubner U, Bodis M, Graeber S, Geisel J. Effect of adding B-vitamins to vitamin D and calcium supplementation on CpG methylation of epigenetic aging markers. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):411-417. doi: 10.1016/j.numecd.2017.12.006. Epub 2017 Dec 29.
- Derived from this study: PubMed 26864355Obeid R, Awwad HM, Rabagny Y, Graeber S, Herrmann W, Geisel J. Plasma trimethylamine N-oxide concentration is associated with choline, phospholipids, and methyl metabolism. Am J Clin Nutr. 2016 Mar;103(3):703-11. doi: 10.3945/ajcn.115.121269. Epub 2016 Feb 10.
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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.
Rima Obeid, PhD principal investigator
Universität des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and Calcium and Vitamin D, Calcium, Vitamins B9, B6, B12 in people with Nutritional Supplement Toxicity, run by Universität des Saarlandes at 1 site 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 12 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in bone formation markers (time frame: baseline, 6 and 12 months). 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 NCT02586181, which also lists 5 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 4 Apr 2019.