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

Universität des Saarlandes

Status: Completed

Conditions: Nutritional Supplement Toxicity

Treatments: Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12; Dietary Supplement: Vitamin D and Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT02586181

Vitamins and bone markers

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 2 patient groups, including a placebo group

Vitamin D and Calcium

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D and Calcium

Vitamin D, Calcium, Vitamins B9, B6, B12

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12