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Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

This study has been completed.
Bio-Tech Pharmacal, Inc.
Information provided by (Responsible Party):
Leigh Eck, MD, University of Kansas Medical Center Research Institute Identifier:
First received: May 14, 2009
Last updated: August 4, 2014
Last verified: August 2014
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 lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.

Condition Intervention
Drug: Vitamin D3
Dietary Supplement: Multivitamin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in Bone Mineral Density (BMD) in HIP at 6 Months [ Time Frame: Change from Baseline to 6 months ]

Secondary Outcome Measures:
  • Change in 25-hyroxyvitamin D Levels at 3 Months [ Time Frame: Change from Baseline to 3 Months ]
    Difference in means between visits

  • Change in 25-hyroxyvitamin D Levels at 6 Months [ Time Frame: Change from Baseline to 6 Months ]
  • Change in Bone Mineral Density (BMD) at HIP at 3 Months [ Time Frame: Change from Baseline to 3 months ]
  • Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months [ Time Frame: Change from Baseline to 3 Months ]
    difference in mean

  • Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months [ Time Frame: Change from Baseline to 6 Months ]
    difference in the mean

Enrollment: 22
Study Start Date: December 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
4000IU Vitamin D3 in tablet taken daily with multivitamin
Drug: Vitamin D3
4000IU vitamin D3 tablet taken daily
Active Comparator: Multivitamin
Multivitamin with 400IU vitamin D tablet
Dietary Supplement: Multivitamin
Multivitamin containing 400IU vitamin D in tablet taken daily

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 important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.

Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Fully lactating mothers age 18 and up
  • Within 1 month after delivery
  • Plan to breast feed for at least 6 months

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00903344

United States, Missouri
University of Kansas Medical Center
Kansas City, Missouri, United States, 66160
Sponsors and Collaborators
Leigh Eck, MD
Bio-Tech Pharmacal, Inc.
Principal Investigator: Leigh Eck, MD University of Kansas Medical Center
  More Information

Responsible Party: Leigh Eck, MD, Assistant Professor, University of Kansas Medical Center Research Institute Identifier: NCT00903344     History of Changes
Other Study ID Numbers: 11711
Study First Received: May 14, 2009
Results First Received: May 22, 2014
Last Updated: August 4, 2014

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 25, 2017