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
• Interventions: Dietary Supplement: Vitamin D and Calcium; Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12

• 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

Arm && Interventions

Group	Intervention	Description
Vitamin D and Calcium	Vitamin D and Calcium	a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
Vitamin D, Calcium, Vitamins B9, B6, 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

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