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

Universität des Saarlandes93 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Nutritional Supplement Toxicity

Interventions

Vitamin D and CalciumDIETARY_SUPPLEMENT

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, B12DIETARY_SUPPLEMENT

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

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Saarland

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

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

Time frame: baseline, 6 and 12 months

Secondary Outcomes

Changes in plasma choline and betaine

plasma choline and betaine (all µmol/L): if both increased indicate saving betaine and choline

Time frame: baseline and aftter 12 months

Changes in global DNA methylation

global DNA methylation \[line 1-methylation (expressed as %)\]

Time frame: baseline and after 12 months

Changes in gene-specific gene methylation

After isolating DNA from whole blood, changes in methylation of targeted genes is studied (expressed as %)

Time frame: baseline and after 12 months

Changes in TMAO

Plasma concentrations of TMAO ((µmol/L) is measured

Time frame: baseline and after 6 and 12 months

Changes in phospholipid concentration in plasma

Plasma phospholipids ((µmol/L) are measured

Time frame: baseline and after 12 months

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

Time frame: baseline, 6 and 12 months

Data from ClinicalTrials.gov

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