|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00860886 |
|
Date of registration:
|
11/03/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
|
|
Scientific title:
|
Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer |
|
Date of first enrolment:
|
March 2, 2009 |
|
Target sample size:
|
412 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00860886 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Mongolia
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Robert N Hoover, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Cancer Institute (NCI) |
| | |
|
Key inclusion & exclusion criteria
|
Participants will be drawn from a group of mothers whose children are participating in a
study that will be conducted by our colleagues at Harvard Medical School. The Harvard study
is a randomized trial among 750 3rd grade children (aged 9-11) to determine the impact of
various types of vitamin D fortified and unfortified milk and vitamin D supplements on
levels of 25(OHD), growth hormone, and IGF-1. Children in this study will be recruited at
eleven primary schools in Ulaanbaatar. The trial will run from January through March 2009
and will include 375 girls; we estimate that their mothers will be roughly 30-45 years of
age, and few will be pregnant.
We plan to recruit participants for our study at the time of the baseline blood draw in
their daughters. Women ages 25-44 are eligible who are not pregnant or breastfeeding.
Age minimum:
25 Years
Age maximum:
44 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Menopause
|
|
Normal Physiology
|
|
Primary Outcome(s)
|
|
hormone measurements
[Time Frame: cross-sectional]
|
|
Secondary ID(s)
|
|
999909078
|
|
09-C-N078
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|