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Clinical Trials/EUCTR2007-001716-23-GB
EUCTR2007-001716-23-GB
Active, not recruiting
Not Applicable

A Double-Blind Randomised Placebo-Controlled Trial of Vitamin D Supplements for Pregnant Women with Low Levels of Vitamin D in Early Pregnancy - MAVIDOS

Southampton University Hospitals NHS Trust0 sites1,000 target enrollmentSeptember 14, 2007
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ConditionsOsteoporosisMedDRA version: 9.1Level: LLTClassification code 10005991Term: Bone mass decreased
DrugsCholecalciferol

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Southampton University Hospitals NHS Trust
Enrollment
1000
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 14, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Southampton University Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • •Pregnant women
  • •serum 25(OH)\-vitamin D concentration is 25\-100 nmol/l at 12 weeks gestation
  • •aged over 18 years
  • •Singleton pregnancy
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Known metabolic bone disease
  • •Current medication likely to interfere with intrauterine growth (corticosteroids, anticonvulsants, PTH, bisphosphonates
  • •foetal physical anomalies on the 12 week scan
  • •inability to provide informed consent or comply with trial protocol.
  • •History of renal stones, hyperparathyroidism, hypercalcuria,
  • •Measured hypercalacemia (\>2\.75mmol/l)
  • •A diagnosis of cancer in the last 10 years
  • •Cod liver oil of vitamin supplements containing vitamin D

Outcomes

Primary Outcomes

Not specified

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