Trial document





This trial has been registered retrospectively.
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  DRKS00003245

Trial Description

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Title

Cross sectional study to investigate the 25-hydroxyvitamin D level and potentially influencing factors of pregnant women and their newborns in Germany

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Trial Acronym

Vitamin D in pregnancy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Vitamin D is a very important factor in a healthy development of the child. Hence, a sufficient vitamin D supply during pregnancy can be very important. Vitamin D is produced in the skin, after exposure to direct sunlight. The consumption of food contributes very little the vitamin D supply. The aim of this study is to assess the vitamin D status of pregnant women and their newborns as well as seasonal effects and the influence of maternal vitamin D status on the status of the newborns.

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Brief Summary in Scientific Language

Vitamin D deficiency has become a public health problem worldwide. In Germany there are limited data available regarding the vitamin D-status, evaluated by serum 25-hydroxyvitamin D (25 OH D), of pregnant women. Only few studies investigated serum parameters, most of the data are based on food frequency questionnaires. We assume that most of the pregnant women in Germany have inadequate 25 OH D-levels and are prone to severe vitamin D insufficiency and vitamin D deficiency.
The aim of this project is to investigate the vitamin D-status of pregnant women and their newborns by determining the serum levels of 25 OH D, parathyroid hormone, alkaline phosphatase and calcium. Due to seasonal changes of 25 OH D a cohort of n=600 subjects is going to be investigated during winter, spring, summer and autumn, n=75 mother-child pairs per season.

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Organizational Data

  •   DRKS00003245
  •   2011/09/07
  •   [---]*
  •   yes
  •   Approved
  •   189/10, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E55.9 -  Vitamin D deficiency, unspecified
  •   E55 -  Vitamin D deficiency
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Interventions/Observational Groups

  •   Vitamin D status of pregnant women and their newborns
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   [---]*
  •   [---]*
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Primary Outcome

Determining maternal and newborn serum 25-hydroxy-vitamin D at time of delivery using chemiluminescence immunoassay (CLIA)

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Secondary Outcome

Maternal serum and cord blood:
parathyroid hormone, alkaline phosphatase and calcium at time of delivery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/03/14
  •   328
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

Pregnant women and their newborns, delivery at the St. Josefs Hospital Giessen

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Exclusion Criteria

Hypercalcaemia, secondary hyperparathyroidism, granulomatosis, malabsorption diseases, history of chronic liver or kidney disease, intake of anticonvulsants or Glucocorticoids, outpatient delivery

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2012/02/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.