Status:
COMPLETED
African-American Bone Metabolism and Lactation Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Lactation
Bone Diseases, Endocrine
Eligibility:
FEMALE
21-45 years
Brief Summary
The primary aim of this study is to obtain measures of amino-terminal telopeptides of procollagen 1 (P1NP), a marker of bone formation, in lactating and non-lactating post-partum African-American wome...
Detailed Description
Pregnancy and lactation are both states of altered maternal calcium and bone metabolism which may have a significant impact on the development of peak bone mass. While these two states are characteriz...
Eligibility Criteria
Inclusion
- Group 1: Post-partum (singleton pregnancy) African-American women who are exclusively breastfeeding, defined as 1 or fewer bottles of supplemental formula/day.
- Group 2: Post-partum (singleton pregnancy) African-American women are non-lactating, which is defined as bottle-feeding or having weaned their baby from breastfeeding for at least 4 weeks prior to study.
- Group 3: Controls- Healthy non-pregnant African-American women will be race and age-matched to the breast-feeding women in group one. They may not have been lactating or pregnant within the last year.
Exclusion
- Subjects with cardiac, hypertensive, vascular, renal (serum creatinine of \>1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease will be excluded from the study.
- Smokers and those with a history of significant alcohol or drug abuse are excluded.
- Baseline hypertension (systolic BP \> 160 mm/Hg) or hypotension (systolic BP \< 90 mm/Hg).
- Subjects taking any chronic medications except stable doses of thyroid hormone, prenatal, vitamin supplements, or oral contraceptives.
- Those who have received any investigational drug in past 90 days will be excluded from the study.
- Women who are currently pregnant will be excluded from the study. Women who became pregnant by In Vitro Fertilization IVF or any hormonal manipulation (i.e. fertility drugs such as clomid ®) are also excluded, as they may have an altered pre-pregnant hormonal state. All women will have a urine pregnancy test performed at each of the two study visits and must not be pregnant in order to continue in the study. Subjects are not allowed to donate blood between study visits.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00785824
Start Date
January 1 2009
End Date
November 1 2010
Last Update
October 31 2013
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213