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Maternal and Infant Vitamin Status During the First Nine Months of Infant Life

Vitamin D Status in the First 9 Months of Life

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02548520
Enrollment
107
Registered
2015-09-14
Start date
2008-10-31
Completion date
2012-03-31
Last updated
2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteomalacia, Osteoporosis, Rickets

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.

Interventions

OTHERBlood and breastmilk samples

The investigators collected maternal and infants blood samples from birth, and 4 and 9 months forward, including breastmilk from the mothers at all visits

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
24 Years to 41 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence in plasma 25OHD and parathyroid hormone at birthat birth (baseline)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).

Secondary

MeasureTime frameDescription
Prevalence in plasma 25OHD and parathyroid hormone at 4 monthsat 4 monthsFor determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 4 months (1. follow-up).
Prevalence in plasma 25OHD and parathyroid hormone at 9 monthsat 9 monthsFor determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 9 months (2. follow-up).

Other

MeasureTime frameDescription
Questionnaire about lifestyle factors at birthat birthAt 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).
peripheral Quantitative Computed Tomography i nine months old infantsat 9 monthsAt 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.
Questionnaire about lifestyle factors at 4 monthsat 4 monthsAt 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).
Questionnaire about lifestyle factors at 9 monthsat 9 monthsAt 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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026