Osteoporosis Clinical Trial
Official title:
Vitamin D Status in the First 9 Months of Life
In this study the investigators wanted to assess vitamin D status and possible consequences of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their infants, in the community of Aarhus, Denmark.
Status | Completed |
Enrollment | 107 |
Est. completion date | March 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 24 Years to 41 Years |
Eligibility |
Inclusion Criteria: - Healthy pregnant Caucasian women aged 24-41 years, - A normal pregnancy giving birth between 38-42 gestational weeks. Exclusion Criteria: - Chronic diseases, - Other ethnic origin than Caucasian, and - Alcohol or drug abuse. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Internal Medicine and Endocrinology, Aarhus University Hospital | Aarhus | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Við Streym S, Kristine Moller U, Rejnmark L, Heickendorff L, Mosekilde L, Vestergaard P. Maternal and infant vitamin D status during the first 9 months of infant life-a cohort study. Eur J Clin Nutr. 2013 Oct;67(10):1022-8. doi: 10.1038/ejcn.2013.152. Epub 2013 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Questionnaire about lifestyle factors at birth | At birth the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (baseline). | at birth | No |
Other | Questionnaire about lifestyle factors at 4 months | At 4 months the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (1. follow up). | at 4 months | No |
Other | Questionnaire about lifestyle factors at 9 months | At 9 months visit the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (2. follow up). | at 9 months | No |
Other | peripheral Quantitative Computed Tomography i nine months old infants | At 9 months the investigators investigated 1) whether there was a correlation between maternal vitamin D status or calcium intake (i.e. diet and supplements) and bone mass and structure as measured by peripheral quantitative computed tomography in the infants 9 months after birth, and 2) gender differences in measured peripheral quantitative computed tomography variables. Furthermore the investigators evaluated 3) the feasibility of performing peripheral quantitative computed tomography scans on newborn infants in terms of assessing the precision of peripheral quantitative computed tomography scan. | at 9 months | No |
Primary | Prevalence in plasma 25OHD and parathyroid hormone at birth | For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled cord blood at baseline. Furthermore the investigators collected maternal blood at 2 weeks after birth (baseline). | at birth (baseline) | No |
Secondary | Prevalence in plasma 25OHD and parathyroid hormone at 4 months | For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 4 months (1. follow-up). | at 4 months | No |
Secondary | Prevalence in plasma 25OHD and parathyroid hormone at 9 months | For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 9 months (2. follow-up). | at 9 months | No |
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