Dairy Foods Compared to Dietary Supplements and Bone Health

Osteoporosis Clinical Trial

— FL-83  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394484
• Other study ID #: WHNRC 201018566-1
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: February 25, 2013
• Start date: December 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Loss
• Osteopenia
• Osteoporosis

Intervention

Other:
• Intervention I
Four servings of dairy foods (milk and yogurt) per day for 42 days.

Dietary Supplement:
• Intervention II
1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No