Clinical trial NCT02586181: Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People (KnoVIB)
Official title: Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Supplement Toxicity
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 93
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* age\> 50 years,
* male and female

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in bone formation markers
timeFrame: baseline, 6 and 12 months
Secondary outcomes:
measure: Changes in plasma choline and betaine
timeFrame: baseline and aftter 12 months
measure: Changes in global DNA methylation
timeFrame: baseline and after 12 months
measure: Changes in gene-specific gene methylation
timeFrame: baseline and after 12 months
measure: Changes in TMAO
timeFrame: baseline and after 6 and 12 months
measure: Changes in phospholipid concentration in plasma
timeFrame: baseline and after 12 months
measure: Changes in concentrations of bone resorption markers
timeFrame: baseline, 6 and 12 months
measure: Changes in plasma homocysteine concentrations
timeFrame: baseline, 6 and 12 months
measure: Changes in plasma levels of folate
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Rima Obeid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hubner 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.
citation: Herrmann 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.
citation: Obeid 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.
citation: Obeid 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.