Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Multivitamin
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitamin D
Multivitamin
Arm Description
4000IU Vitamin D3 in tablet taken daily with multivitamin
Multivitamin with 400IU vitamin D tablet
Outcomes
Primary Outcome Measures
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Secondary Outcome Measures
Change in 25-hyroxyvitamin D Levels at 3 Months
Difference in means between visits
Change in 25-hyroxyvitamin D Levels at 6 Months
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
difference in mean
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
difference in the mean
Full Information
NCT ID
NCT00903344
First Posted
May 14, 2009
Last Updated
August 4, 2014
Sponsor
Leigh Eck, MD
Collaborators
Bio-Tech Pharmacal, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00903344
Brief Title
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Official Title
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leigh Eck, MD
Collaborators
Bio-Tech Pharmacal, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
4000IU Vitamin D3 in tablet taken daily with multivitamin
Arm Title
Multivitamin
Arm Type
Active Comparator
Arm Description
Multivitamin with 400IU vitamin D tablet
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
4000IU vitamin D3 tablet taken daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamin
Intervention Description
Multivitamin containing 400IU vitamin D in tablet taken daily
Primary Outcome Measure Information:
Title
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Time Frame
Change from Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in 25-hyroxyvitamin D Levels at 3 Months
Description
Difference in means between visits
Time Frame
Change from Baseline to 3 Months
Title
Change in 25-hyroxyvitamin D Levels at 6 Months
Time Frame
Change from Baseline to 6 Months
Title
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Time Frame
Change from Baseline to 3 months
Title
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
Description
difference in mean
Time Frame
Change from Baseline to 3 Months
Title
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
Description
difference in the mean
Time Frame
Change from Baseline to 6 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Eck, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
We'll reach out to this number within 24 hrs