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Dairy Foods Compared to Dietary Supplements and Bone Health

Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01394484
Acronym
FL-83
Enrollment
12
Registered
2011-07-14
Start date
2010-12-31
Completion date
2013-02-28
Last updated
2013-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Osteopenia, Osteoporosis

Brief summary

Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.

Detailed description

Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.

Interventions

Four servings of dairy foods (milk and yogurt) per day for 42 days.

DIETARY_SUPPLEMENTIntervention II

1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days

Sponsors

Dairy Management Inc.
CollaboratorINDUSTRY
USDA, Western Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Ratio of 41Ca/40Ca excreted in urineDays 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 studySubjects 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026