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Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People

NCT00696514 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2011-08-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • MCO Health

    collaborator UNKNOWN

  • Erasmus Medical Center

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • NZO: Dutch Dairy Association

    collaborator UNKNOWN

  • Wageningen University

    lead OTHER

Principal Investigators

  • Lisette CPGM de Groot, Prof · Wageningen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696514 on ClinicalTrials.gov