Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People (KnoVIB)
KnoVIB
1 other identifier
interventional
93
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedApril 4, 2019
April 1, 2019
1.9 years
October 21, 2015
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
baseline, 6 and 12 months
Secondary Outcomes (8)
Changes in plasma choline and betaine
baseline and aftter 12 months
Changes in global DNA methylation
baseline and after 12 months
Changes in gene-specific gene methylation
baseline and after 12 months
Changes in TMAO
baseline and after 6 and 12 months
Changes in phospholipid concentration in plasma
baseline and after 12 months
- +3 more secondary outcomes
Study Arms (2)
Vitamin D and Calcium
PLACEBO COMPARATORa combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
Vitamin D, Calcium, Vitamins B9, B6, B12
EXPERIMENTALa 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- age\> 50 years,
- male and female
You may not qualify if:
- renal dysfunction,
- recent stroke or coronary event within the last 3 months,
- current cancer,
- antifolate treatment,
- ileum resection,
- existing B vitamins supplementation,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saarland
Homburg, Saarland, 66424, Germany
Related Publications (5)
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.
PMID: 25283139RESULTHubner 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.
PMID: 23314556RESULTHerrmann 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.
PMID: 23183751RESULTObeid 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.
PMID: 29395637DERIVEDObeid 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.
PMID: 26864355DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rima Obeid, PhD
Universität des Saarlandes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. (apl.) Dr.
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 26, 2015
Study Start
August 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
April 4, 2019
Record last verified: 2019-04