Impact of Vitamin D Supplementation on Lactation Associated Bone Loss - NCT00903344-66160 (Clinical Trial 292925)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy292925.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Kansas City |
|
State:
|
|
MO |
| Zip Code: |
|
66160 |
| Conditions: |
|
Osteoporosis |
| Purpose: |
|
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 summary: |
|
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. |
| 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 |
|
|
|
| Study is available at: |
|
University of Kansas Medical Center
Kansas City, MO 66160
United States
Primary Contact:
Leigh Eck, MD
Email: LECK2@kumc.edu
Phone: 913-588-6022 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|