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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and Calcium | Placebo Comparator | a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate |
|
| Vitamin D, Calcium, Vitamins B9, B6, B12 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D and Calcium | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in global DNA methylation |
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Inclusion Criteria:
Exclusion Criteria:
Termination criteria were:
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| Name | Affiliation | Role |
|---|---|---|
| Rima Obeid, PhD | Universität des Saarlandes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saarland | Homburg | Saarland | 66424 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25283139 | Result | Kirsch SH, Herrmann W, Kruse V, Eckert R, Graber 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. | |
| 23314556 | Result | Hubner 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-2012-0624. |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002118 | Calcium |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Vitamin D, Calcium, Vitamins B9, B6, B12 | Dietary 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 |
|
global DNA methylation [line 1-methylation (expressed as %)]
| 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 %) | baseline and after 12 months |
| Changes in TMAO | Plasma concentrations of TMAO ((µmol/L) is measured | baseline and after 6 and 12 months |
| Changes in phospholipid concentration in plasma | Plasma phospholipids ((µmol/L) are measured | 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 | baseline, 6 and 12 months |
| Changes in plasma homocysteine concentrations | changes in plasma homocysteine (µmol/L) between the time points | baseline, 6 and 12 months |
| Changes in plasma levels of folate | changes in serum and whole blood folate (nmol/L) | baseline, 6 and 12 months |
| 23183751 | Result | Herrmann W, Kirsch SH, Kruse V, Eckert R, Graber 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. |
| 29395637 | Derived | Obeid R, Hubner U, Bodis M, Graeber S, Geisel J. Effect of adding B-vitamins to vitamin D and calcium supplementation on CpG methylation of epigenetic aging markers. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):411-417. doi: 10.1016/j.numecd.2017.12.006. Epub 2017 Dec 29. |
| 26864355 | Derived | Obeid R, Awwad HM, Rabagny Y, Graeber S, Herrmann W, Geisel J. Plasma trimethylamine N-oxide concentration is associated with choline, phospholipids, and methyl metabolism. Am J Clin Nutr. 2016 Mar;103(3):703-11. doi: 10.3945/ajcn.115.121269. Epub 2016 Feb 10. |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |