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Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

This study has been completed.
Sponsor:
Collaborator:
Bio-Tech Pharmacal, Inc.
Information provided by (Responsible Party):
Leigh Eck, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00903344
First received: May 14, 2009
Last updated: August 4, 2014
Last verified: August 2014

May 14, 2009
August 4, 2014
December 2009
June 2012   (final data collection date for primary outcome measure)
Change in Bone Mineral Density (BMD) in HIP at 6 Months [ Time Frame: Change from Baseline to 6 months ] [ Designated as safety issue: No ]
Change in absolute bone mineral density (BMD) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00903344 on ClinicalTrials.gov Archive Site
  • Change in 25-hyroxyvitamin D Levels at 3 Months [ Time Frame: Change from Baseline to 3 Months ] [ Designated as safety issue: No ]
    Difference in means between visits
  • Change in 25-hyroxyvitamin D Levels at 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Change in Bone Mineral Density (BMD) at HIP at 3 Months [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]
  • Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months [ Time Frame: Change from Baseline to 3 Months ] [ Designated as safety issue: No ]
    difference in mean
  • Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
    difference in the mean
Changes in lab values for vitamin D, calcium, parathyroid hormone, bone turnover markers, calcium-to-creatinine ratio [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Osteoporosis
  • Drug: Vitamin D3
    4000IU vitamin D3 tablet taken daily
  • Dietary Supplement: Multivitamin
    Multivitamin containing 400IU vitamin D in tablet taken daily
  • Experimental: Vitamin D
    4000IU Vitamin D3 in tablet taken daily with multivitamin
    Intervention: Drug: Vitamin D3
  • Active Comparator: Multivitamin
    Multivitamin with 400IU vitamin D tablet
    Intervention: Dietary Supplement: Multivitamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00903344
11711
No
Leigh Eck, MD, University of Kansas Medical Center Research Institute
Leigh Eck, MD
Bio-Tech Pharmacal, Inc.
Principal Investigator: Leigh Eck, MD University of Kansas
University of Kansas
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP