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Completed

NCT Number: NCT02586181

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

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.

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Key information

Conditions

Nutritional Supplement Toxicity

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saarland

Homburg, Saarland, 66424, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Changes in bone formation markers

    Time frame: 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 outcomes

  1. Changes in plasma choline and betaine

    Time frame: baseline and aftter 12 months

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

  2. Changes in global DNA methylation

    Time frame: baseline and after 12 months

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

  3. Changes in gene-specific gene methylation

    Time frame: baseline and after 12 months

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

  4. Changes in TMAO

    Time frame: baseline and after 6 and 12 months

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

  5. Changes in phospholipid concentration in plasma

    Time frame: baseline and after 12 months

    Plasma phospholipids ((µmol/L) are measured

  6. Changes in concentrations of bone resorption markers

    Time frame: 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

  7. Changes in plasma homocysteine concentrations

    Time frame: baseline, 6 and 12 months

    changes in plasma homocysteine (µmol/L) between the time points

  8. Changes in plasma levels of folate

    Time frame: baseline, 6 and 12 months

    changes in serum and whole blood folate (nmol/L)

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

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

Acronym: KnoVIB

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 26, 2015
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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