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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nutritional Supplement Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Vitamin D and Calcium

a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate

Group Type PLACEBO_COMPARATOR

Vitamin D and Calcium

Intervention Type 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

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

Group Type EXPERIMENTAL

Vitamin D, Calcium, Vitamins B9, B6, B12

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes