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Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People (B-PROOF)

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ClinicalTrials.gov Identifier: NCT00696514
Recruitment Status : Unknown
Verified August 2011 by Wageningen University.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2008
Last Update Posted : August 25, 2011
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
MCO Health
Erasmus Medical Center
VU University Medical Center
NZO: Dutch Dairy Association
Information provided by:
Wageningen University

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 12, 2008
Last Update Posted Date August 25, 2011
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
Fractures [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
Official Title  ICMJE Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoporosis
  • Cognitive Decline
Intervention  ICMJE
  • 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
  • Dietary Supplement: Placebo (Vitamin D3) - 600 IU per day
    600 IU vitamin D3 in one capsule, once per day
Study Arms  ICMJE
  • Placebo Comparator: 2
    placebo capsule, once per day
    Intervention: Dietary Supplement: Placebo (Vitamin D3) - 600 IU per day
  • Experimental: 1
    Vitamin B12 and folic acid capsule, once a day
    Intervention: Dietary Supplement: Vitamin B12, folic acid, Vitamin D3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2008)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 65 years and older; based on entry date into study;
  • Fasting plasma Hcy level >= 12 µmol/L and < 50 µmol/L;
  • No current or recent (<4 months) use of supplements with very high doses of B-vitamins;
  • Competent to make own decisions;
  • Persons with skin cancer are allowed to participate.
  • Compliance to tablet intake > 85%

Exclusion Criteria:

  • Participation in other intervention trials;
  • Serious medical conditions, e.g. cancer diagnosis within the last 5 years or recent myocardial infarction;
  • Immobilization (bedridden, wheelchair bound);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00696514
Other Study ID Numbers  ICMJE ZonMw 6130.0031
NTR1333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZonMw: The Netherlands Organisation for Health Research and Development
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • MCO Health
  • Erasmus Medical Center
  • VU University Medical Center
  • NZO: Dutch Dairy Association
Investigators  ICMJE
Principal Investigator: Lisette CPGM de Groot, Prof Wageningen University
PRS Account Wageningen University
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP