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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
22
4000IU vitamin D3 tablet taken daily
Multivitamin containing 400IU vitamin D in tablet taken daily
University of Kansas Medical Center
Kansas City, Missouri, United States
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Time frame: Change from Baseline to 6 months
Change in 25-hyroxyvitamin D Levels at 3 Months
Difference in means between visits
Time frame: Change from Baseline to 3 Months
Change in 25-hyroxyvitamin D Levels at 6 Months
Time frame: Change from Baseline to 6 Months
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Time frame: Change from Baseline to 3 months
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
difference in mean
Time frame: Change from Baseline to 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
difference in the mean
Time frame: Change from Baseline to 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.