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Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

NCT00903344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-08-18

Study results available
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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.

Conditions

Interventions

DRUG

Vitamin D3

4000IU vitamin D3 tablet taken daily

DIETARY_SUPPLEMENT

Multivitamin

Multivitamin containing 400IU vitamin D in tablet taken daily

Sponsors & Collaborators

  • Bio-Tech Pharmacal, Inc.

    collaborator INDUSTRY

  • Leigh Eck, MD

    lead OTHER

Principal Investigators

  • Leigh Eck, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903344 on ClinicalTrials.gov