Dairy Foods Compared to Dietary Supplements and Bone Health
FL-83
Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
1 other identifier
interventional
12
1 country
1
Brief Summary
Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 26, 2013
February 1, 2013
2.2 years
July 12, 2011
February 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of 41Ca/40Ca excreted in urine
Subjects will be asked to collect 24 hour urine samples to establish each individual's kinetic profile of Ca excretion and to measure the effectiveness of the interventions.
Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study
Study Arms (2)
Arm 1
EXPERIMENTALFour servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days
Arm 2
EXPERIMENTALDietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.
Interventions
1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days
Eligibility Criteria
You may qualify if:
- Minimum 24 months since last menses
- No hormone therapy in the past 12 months
- Weight stable for the past 3 months
- Bone density T score -1.7 to 0.0
- No more than two dairy servings per day
- No history of inflammatory disorders
- No history of non-traumatic bone fracture
- No supplement use or willing to discontinue
- No lactose intolerance
- Willing to consume milk and yogurt
You may not qualify if:
- Less than 24 months since last menses
- Use of hormone therapy in past yr
- \> 5 pound weight change in past 3 months
- Osteoporosis
- Regular \>2 servings/d of dairy
- Auto-immune/inflammatory disorders
- History of non-traumatic bone fracture
- Unwilling to discontinue supplements
- Lactose intolerance
- Unwilling to eat yogurt or drink milk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Human Nutrition Research Center
Davis, California, 95616, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Van Loan, PhD
WHNRC, ARS, University of California Davis
- STUDY DIRECTOR
Marjorie Garrod, Ph.D.
USDA, ARS, WHNRC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 14, 2011
Study Start
December 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 26, 2013
Record last verified: 2013-02