Status:
COMPLETED
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Lead Sponsor:
Leigh Eck, MD
Collaborating Sponsors:
Bio-Tech Pharmacal, Inc.
Conditions:
Osteoporosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactati...
Detailed Description
Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide im...
Eligibility Criteria
Inclusion
- Fully lactating mothers age 18 and up
- Within 1 month after delivery
- Plan to breast feed for at least 6 months
Exclusion
- Known metabolic bone disease
- Chronic renal insufficiency
- Chronic corticosteroid use
- Eating disorder
- Estrogen containing hormonal contraception use
- Daily use of \>400IU Vitamin D supplementation
- Delivery of Multiples
- Delivery of a singleton with a birth weight of \<2500 grams
- Preterm delivery of baby
- History of kidney stones
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00903344
Start Date
December 1 2009
End Date
June 1 2012
Last Update
August 18 2014
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Missouri, United States, 66160