A Phase 1 interventional study of Vitamin B12, folic acid, Vitamin D3 and Placebo (Vitamin D3) - 600 IU per day in Osteoporosis and Cognitive Decline, sponsored by Wageningen University. Status unknown at 3 sites in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-25.
Sponsored by Wageningen University · Phase 1, Interventional, and Prevention
It is hypothesized that vitamin B12 and folic acid supplementation reduces the number of incident fractures. The proposed study, a randomized placebo-controlled intervention trial, compares daily supplementation with folic acid (400 mcg) and vitamin B12 (500 mcg) to a placebo for a period of two years or longer in 3000 men and women aged 70 years and older, with initial basal plasma total homocysteine (tHcy) levels >= 15 micromol/L. Fracture incidence and time to fracture will be assessed and used as the efficacy measure.
Metabolic studies in a sub sample of the population will be included aiming to contribute to an understanding of the biological mechanisms underlying the associations found between markers of B-vitamin status and bone quality.
Rationale: There is growing evidence that an elevated homocysteine level is a risk factor for fracture incidence. The most common cause of homocysteine elevation is poor vitamin B12 and folate status. It is hypothesized that supplementation with 500 µg vitamin B12 and 400 µg folic acid will reduce fracture incidence in elderly people Main objective: to determine the efficacy of oral supplementation with vitamin B12 and folic acid in the prevention of fractures Study design: The trial is a randomized double-blind placebo-controlled trial, with two arms in parallel (placebo versus supplement). The intervention comprises a period of two years, and will be targeted to 3000 elderly subjects with elevated homocysteine levels. The study will be performed in institutions or residences for older persons around Wageningen, Rotterdam and Amsterdam.
Study population: 3000 elderly subjects (70 years and older) with elevated homocysteine levels Intervention (if applicable): One group receives daily a tablet with 500 µg vitamin B12 and 400 ug folic acid and the other group receives daily a placebo tablet. In both tablets 15 µg (600 IU) of vitamin D is included as well.
Main study parameters/endpoints: Fracture incidence is the primary outcome measure Time to fracture will be calculated. It is expected that in the intervention group 34% less fractures will occur than in the placebo group.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: First, participants need to be recruited. This will be done via information letters. Those who are interested have to complete a small questionnaire and then they will receive an information brochure. Upon continued interest in the intervention study, participants will be invited for a blood sampling. This blood sampling will take place (nearby or) at the location where the participants live. Immediately after the blood sampling a run-in period will start. Blood will be checked on homocysteine levels. Only participants with elevated levels of homocysteine will be included in the study. Two to four weeks after the run-in period the intervention study will be implemented. At the start of this intervention study several measurements will be performed and several questionnaires will be completed together with the participant at home. During the whole study participants need to take daily one tablet and they have to complete calenders to monitor fracture incidence. At the end of the study, blood sampling will be performed and several measurements and questionnaires will be repeated again at home.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
placebo capsule, once per day
Dietary Supplement: Placebo (Vitamin D3) - 600 IU per day
Vitamin B12 and folic acid capsule, once a day
Dietary Supplement: Vitamin B12, folic acid, Vitamin D3
500 µg vitamin B12; 0.4 mg folic acid; 600 IU vitamin D3 in one capsule, once per day
600 IU vitamin D3 in one capsule, once per day
Fractures
Time frame: two years
Cognitive decline
Time frame: two years
Bone health
Time frame: two years
Physical performance
Time frame: two years
Quality of life
Time frame: two years
Nutritional status
Time frame: two years
This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Wageningen University