NCT00903344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 18, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

May 14, 2009

Results QC Date

May 22, 2014

Last Update Submit

August 4, 2014

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change in Bone Mineral Density (BMD) in HIP at 6 Months

    Change from Baseline to 6 months

Secondary Outcomes (5)

  • Change in 25-hyroxyvitamin D Levels at 3 Months

    Change from Baseline to 3 Months

  • Change in 25-hyroxyvitamin D Levels at 6 Months

    Change from Baseline to 6 Months

  • Change in Bone Mineral Density (BMD) at HIP at 3 Months

    Change from Baseline to 3 months

  • Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months

    Change from Baseline to 3 Months

  • Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months

    Change from Baseline to 6 Months

Study Arms (2)

Vitamin D

EXPERIMENTAL

4000IU Vitamin D3 in tablet taken daily with multivitamin

Drug: Vitamin D3

Multivitamin

ACTIVE COMPARATOR

Multivitamin with 400IU vitamin D tablet

Dietary Supplement: Multivitamin

Interventions

Vitamin D3DRUG

4000IU vitamin D3 tablet taken daily

Vitamin D
MultivitaminDIETARY_SUPPLEMENT

Multivitamin containing 400IU vitamin D in tablet taken daily

Multivitamin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully lactating mothers age 18 and up
  • Within 1 month after delivery
  • Plan to breast feed for at least 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

CholecalciferolGeritol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Leigh Eck
Organization
University of Kansas Medical Center
leck2@kumc.edu
913-588-6022

Study Officials

  • Leigh Eck, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 18, 2014

Results First Posted

August 18, 2014

Record last verified: 2014-08

Locations

US(1)