Nutritional Supplement Toxicity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin 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
DIETARY_SUPPLEMENTVitamin 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
Sponsors
Universität des Saarlandes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in global DNA methylation | baseline and after 12 months | global DNA methylation \[line 1-methylation (expressed as %)\] |
| 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 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 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 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) |
| Changes in phospholipid concentration in plasma | baseline and after 12 months | Plasma phospholipids ((µmol/L) are measured |
Countries
Germany
Outcome results
None listed