Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Vitamin D3; Dietary supplement: Multivitamin

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Bone Mineral Density (BMD) in HIP at 6 Months	Change from Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 25-hyroxyvitamin D Levels at 3 Months	Difference in means between visits	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	difference in mean	Change from Baseline to 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months	difference in the mean	Change from Baseline to 6 Months

Collaborators and Investigators

• Sponsor: Leigh Eck, MD
• Collaborators: Bio-Tech Pharmacal, Inc.
• Investigators: Principal Investigator: Leigh Eck, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: May 14, 2009
• First Submitted That Met QC Criteria: May 15, 2009
• First Posted (ESTIMATE): May 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 18, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 11711