An observational study in Rickets, Osteomalacia and Osteoporosis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 24 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-14.
Sponsored by University of Aarhus · Observational
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.
Danish people living at northern latitudes (56°N), often with overcast and foggy weather and few sunshine hours are at increased risk of vitamin D insufficiency. Although vitamin D is obtainable from fortified food and oily fish, the major source is the dermal synthesis of the vitamin D through exposure to solar ultraviolet light.
In the 19th century rickets was endemic in northern Europe, and many children developed rickets, a severe bone-deforming disease. Encouragement of sensible sun exposure, supplementation with cod liver oil and fortification of milk with vitamin D, resulted in an almost complete eradication of rickets by the end of the 19th century. At present vitamin D deficiency seems again to be more widespread. The classical outcomes of severe vitamin D deficiency are rickets in growing individuals and osteomalacia in adults. Low vitamin D status also relates to low bone density and increased risk of osteoporotic fractures. Although the incidence of rickets has declined over the last decades, cases attributable to inadequate vitamin D intake and low exposure to sunlight continue to be reported, and maternal vitamin D status may have permanent effects on newborns' health. Pregnant women, newborns, breastfed children, and lactating women are at a high risk of vitamin D deficiency, especially during winter and early spring.
Since fetal plasma 25-hydroxyvitamin D (25OHD) depends on maternal 25OHD, fetal vitamin D status may show seasonal changes parallel to those observed in the mothers. To prevent rickets and vitamin D deficiency in infants, most Western countries, including Denmark, recommend a daily maternal intake during pregnancy and lactation of 10 μg and that breastfed children are given a supplement of 10 μg of vitamin D/day. Despite these recommendations, approximately one third of Danish pregnant and lactating women have vitamin D insufficiency. However, childhood rickets is nowadays rare in Denmark, although it still exists especially among immigrants and mothers with prolonged lactation. Accordingly, in 2010, the Danish National Board of Health extended the recommendations for vitamin D supplementation to the first two years of life.
34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.
This study's enrollment of 107 is above the median of 65 across 14 observational studies indexed under Osteomalacia.
Browse Osteomalacia studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Compared within Osteomalacia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rickets. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Healthy pregnant Caucasian women with a normal pregnancy
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The investigators collected maternal and infants blood samples from birth, and 4 and 9 months forward, including breastmilk from the mothers at all visits
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).
Time frame: at birth (baseline)
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).
Time frame: at 4 months
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).
Time frame: at 9 months
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).
Time frame: at birth
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).
Time frame: at 4 months
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).
Time frame: at 9 months
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.
Time frame: at 9 months
The record gives a start of Oct 2008, a primary completion of Jul 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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