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Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

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ClinicalTrials.gov Identifier: NCT00903344
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
Bio-Tech Pharmacal, Inc.
Information provided by (Responsible Party):
Leigh Eck, MD, University of Kansas Medical Center

Study Description
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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 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 or disease Intervention/treatment Phase
Osteoporosis Drug: Vitamin D3 Dietary Supplement: Multivitamin Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Study Start Date : December 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

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

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

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


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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903344


Locations
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United States, Missouri
University of Kansas Medical Center
Kansas City, Missouri, United States, 66160
Sponsors and Collaborators
Leigh Eck, MD
Bio-Tech Pharmacal, Inc.
Investigators
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Principal Investigator: Leigh Eck, MD University of Kansas Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Leigh Eck, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00903344    
Other Study ID Numbers: 11711
First Posted: May 18, 2009    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
 Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents