Clinical trial NCT02548520: Maternal and Infant Vitamin Status During the First Nine Months of Infant Life
Official title: Vitamin D Status in the First 9 Months of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rickets
Osteomalacia
Osteoporosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 107
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant Caucasian women with a normal pregnancy

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence in plasma 25OHD and parathyroid hormone at birth
timeFrame: at birth (baseline)
Secondary outcomes:
measure: Prevalence in plasma 25OHD and parathyroid hormone at 4 months
timeFrame: at 4 months
measure: Prevalence in plasma 25OHD and parathyroid hormone at 9 months
timeFrame: at 9 months
Other outcomes:
measure: Questionnaire about lifestyle factors at birth
timeFrame: at birth
measure: Questionnaire about lifestyle factors at 4 months
timeFrame: at 4 months
measure: Questionnaire about lifestyle factors at 9 months
timeFrame: at 9 months
measure: peripheral Quantitative Computed Tomography i nine months old infants
timeFrame: at 9 months
Locations:
city: Aarhus
country: Denmark
facility: Department of Internal Medicine and Endocrinology, Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: Department of Internal Medicine and Endocrinology, Aarhus University Hospital
name: Susanna við Streym, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine and Endocrinology, Aarhus University Hospital
name: Lars Rejnmark, Professor
role: STUDY_DIRECTOR
affiliation: The Department of Endocrinology, Aalborg University Hospital
name: Peter Vestergaard, Professor
role: STUDY_CHAIR
References:
citation: Vieth 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.
citation: vieth Streym S, Hojskov CS, Moller UK, Heickendorff L, Vestergaard P, Mosekilde L, Rejnmark L. Vitamin D content in human breast milk: a 9-mo follow-up study. Am J Clin Nutr. 2016 Jan;103(1):107-14. doi: 10.3945/ajcn.115.115105. Epub 2015 Dec 16.