Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People (KnoVIB)

Nutritional Supplement Toxicity Clinical Trial

— KnoVIB  

Official title:

Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586181
• Other study ID #: Vitamins and bone markers
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: April 2019
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutritional Supplement Toxicity

Intervention

Dietary Supplement:
• Vitamin D and Calcium
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, 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

Locations

Country	Name	City	State
Germany	University of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Herrmann W, Kirsch SH, Kruse V, Eckert R, Gräber 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. — View Citation

Hübner 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- — View Citation

Kirsch SH, Herrmann W, Kruse V, Eckert R, Gräber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in plasma choline and betaine	plasma choline and betaine (all µmol/L): if both increased indicate saving betaine and choline	baseline and aftter 12 months
Secondary	Changes in global DNA methylation	global DNA methylation [line 1-methylation (expressed as %)]	baseline and after 12 months
Secondary	Changes in gene-specific gene methylation	After isolating DNA from whole blood, changes in methylation of targeted genes is studied (expressed as %)	baseline and after 12 months
Secondary	Changes in TMAO	Plasma concentrations of TMAO ((µmol/L) is measured	baseline and after 6 and 12 months
Secondary	Changes in phospholipid concentration in plasma	Plasma phospholipids ((µmol/L) are measured	baseline and after 12 months
Secondary	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	baseline, 6 and 12 months
Secondary	Changes in plasma homocysteine concentrations	changes in plasma homocysteine (µmol/L) between the time points	baseline, 6 and 12 months
Secondary	Changes in plasma levels of folate	changes in serum and whole blood folate (nmol/L)	baseline, 6 and 12 months