Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

NCT ID: NCT00903344

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D

4000IU Vitamin D3 in tablet taken daily with multivitamin

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

4000IU vitamin D3 tablet taken daily

Multivitamin

Multivitamin with 400IU vitamin D tablet

Group Type: ACTIVE_COMPARATOR

Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin containing 400IU vitamin D in tablet taken daily

Interventions

Vitamin D3

4000IU vitamin D3 tablet taken daily

Intervention Type: DRUG

Multivitamin

Multivitamin containing 400IU vitamin D in tablet taken daily

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bio-Tech Pharmacal, Inc.

INDUSTRY

Sponsor Role: collaborator

Leigh Eck, MD

OTHER

Sponsor Role: lead

Responsible Party

Leigh Eck, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leigh Eck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

11711

Identifier Type: -

Identifier Source: org_study_id