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

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ClinicalTrials.gov Identifier: NCT02586181
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rima Obeid, 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.

Condition or disease Intervention/treatment Phase
Nutritional Supplement Toxicity Dietary Supplement: Vitamin D and Calcium Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People
Study Start Date : August 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
Placebo Comparator: Vitamin D and Calcium
a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
Dietary Supplement: Vitamin 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


Experimental: 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
Dietary Supplement: 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 :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586181


Locations
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Germany
University of Saarland
Homburg, Saarland, Germany, 66424
Sponsors and Collaborators
Universität des Saarlandes
Investigators
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Principal Investigator: Rima Obeid, PhD Universität des Saarlandes
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rima Obeid, Prof. (apl.) Dr., Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT02586181    
Other Study ID Numbers: Vitamins and bone markers
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Folic Acid
Calcium
Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Vitamin B Complex
Hematinics