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

Not Applicable

Completed

• Conditions: Nutritional Supplement Toxicity

• Registration Number: NCT02586181
• Lead Sponsor: Universität des Saarlandes

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in bone formation markers	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

Secondary Outcome Measures

Name	Time	Method
Changes in global DNA methylation	baseline and after 12 months	global DNA methylation \[line 1-methylation (expressed as %)\]
Changes in concentrations of bone resorption markers	baseline, 6 and 12 months	concentrations of bone resorption markers \[plasma TRAP5b (U/L), urine DPD (nmol//mmol creatinine)\]: if both are increased indicate enhanced bone resorption
Changes in plasma choline and betaine	baseline and aftter 12 months	plasma choline and betaine (all µmol/L): if both increased indicate saving betaine and choline
Changes in gene-specific gene methylation	baseline and after 12 months	After isolating DNA from whole blood, changes in methylation of targeted genes is studied (expressed as %)
Changes in TMAO	baseline and after 6 and 12 months	Plasma concentrations of TMAO ((µmol/L) is measured
Changes in phospholipid concentration in plasma	baseline and after 12 months	Plasma phospholipids ((µmol/L) are measured
Changes in plasma homocysteine concentrations	baseline, 6 and 12 months	changes in plasma homocysteine (µmol/L) between the time points
Changes in plasma levels of folate	baseline, 6 and 12 months	changes in serum and whole blood folate (nmol/L)

Trial Locations

Locations (1)

University of Saarland; 🇩🇪 Homburg, Saarland, Germany