Clinical trial NCT00903344: Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Official title: Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Bio-Tech Pharmacal, Inc.
First posted: 2009-05-18
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Bone Mineral Density (BMD) in HIP at 6 Months
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Change in 25-hyroxyvitamin D Levels at 3 Months
timeFrame: Change from Baseline to 3 Months
measure: Change in 25-hyroxyvitamin D Levels at 6 Months
timeFrame: Change from Baseline to 6 Months
measure: Change in Bone Mineral Density (BMD) at HIP at 3 Months
timeFrame: Change from Baseline to 3 months
measure: Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
timeFrame: Change from Baseline to 3 Months
measure: Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
timeFrame: Change from Baseline to 6 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Leigh Eck, MD
role: PRINCIPAL_INVESTIGATOR
References: