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
  Purpose

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
Osteoporosis
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:

Primary Outcome Measures:
  • Change in Bone Mineral Density (BMD) in HIP at 6 Months [ Time Frame: Change from Baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903344

Locations
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
Principal Investigator: Leigh Eck, MD University of Kansas
  More Information

No publications provided

Responsible Party: Leigh Eck, MD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014