Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Osteoporosis Clinical Trial

Official title:

Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903344
• Other study ID #: 11711
• Status: Completed
• Phase: N/A
• First received: May 14, 2009
• Last updated: August 4, 2014
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Vitamin D3
4000IU vitamin D3 tablet taken daily

Dietary Supplement:
• Multivitamin
Multivitamin containing 400IU vitamin D in tablet taken daily

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Leigh Eck, MD	Bio-Tech Pharmacal, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone Mineral Density (BMD) in HIP at 6 Months		Change from Baseline to 6 months	No
Secondary	Change in 25-hyroxyvitamin D Levels at 3 Months	Difference in means between visits	Change from Baseline to 3 Months	No
Secondary	Change in 25-hyroxyvitamin D Levels at 6 Months		Change from Baseline to 6 Months	No
Secondary	Change in Bone Mineral Density (BMD) at HIP at 3 Months		Change from Baseline to 3 months	No
Secondary	Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months	difference in mean	Change from Baseline to 3 Months	No
Secondary	Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months	difference in the mean	Change from Baseline to 6 Months	No