Calcium and Vitamin D Malnutrition in Elderly Women
1 other identifier
interventional
1,180
0 countries
N/A
Brief Summary
This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures, reduces high parathyroid secretory activity, and halts bone loss in a population-based sample of women 55+ years of age.
- A calcium supplement of 1400 mg/d will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living, rural women 55 years of age and older compared to similar women on their usual diets.
- A calcium supplement of 1400 mg/d plus 1100 IU vitamin D/d will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2000
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 12, 2006
CompletedFirst Posted
Study publicly available on registry
July 14, 2006
CompletedAugust 11, 2008
August 1, 2008
5.2 years
July 12, 2006
August 8, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fractures
4 years
Secondary Outcomes (5)
changes in bone mass and density
4 years
changes in serum dihydroxyvitamin D
one year and four years
changes in serum parathyroid hormone
one year and four years
cancer
four years
Falls
four years
Study Arms (3)
1
EXPERIMENTALcalcium supplementation
2
EXPERIMENTALcalcium and vitamin D3 supplementation
3
EXPERIMENTALplacebo
Interventions
calcium carbonate 1500 mg/day vitamin D3 1000 IU/day
Eligibility Criteria
You may not qualify if:
- \) chronic kidney disease, 2) Paget's metabolic bone disease, and 3) history of cancer except for superficial basal or squamous cell carcinoma of the skin and
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- GlaxoSmithKlinecollaborator
Related Publications (2)
Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. doi: 10.1093/ajcn/85.6.1586.
PMID: 17556697RESULTZhou Y, Zhao LJ, Xu X, Ye A, Travers-Gustafson D, Zhou B, Wang HW, Zhang W, Lee Hamm L, Deng HW, Recker RR, Lappe JM. DNA methylation levels of CYP2R1 and CYP24A1 predict vitamin D response variation. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt A:207-14. doi: 10.1016/j.jsbmb.2013.10.004. Epub 2013 Oct 12.
PMID: 24128439DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan M Lappe, Ph.D
Creighton University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2006
First Posted
July 14, 2006
Study Start
May 1, 2000
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
August 11, 2008
Record last verified: 2008-08