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Completed

NCT Number: NCT01723852

Vitamin D Intervention in Infants

The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.

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Key information

Conditions

Vitamin D Status Communicable Diseases Disease Attributes Hypersensitivity Immune System Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kätilöopisto Maternity Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

Exclusion criteria

  • Non Caucasian mother
  • Any continuous regular medication of mother
  • Treatment at neonatal intensive care unit
  • Antibiotic treatment of the infant
  • Congenital malformations of the newborn
  • Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
  • Glucose infusion of the newborn
  • Neurological symptoms of the newborn
  • Phototherapy for jaundice of the newborn
  • Need for nasogastric feeding of the newborn

Treatment and study plan

Vitamin D at 30 ug/day

Dietary Supplement

Vitamin D at 10 ug/day

Dietary Supplement

Primary outcomes

  1. Growth

    Time frame: 2 years of age

    Measurement of growth at 2 years of age

  2. Neurologic and cognitive development

    Time frame: At 2 years of age

    By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development

  3. Frequency of allergic symptoms and infection

    Time frame: At 2 years of age

    Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.

  4. Development of immunoregulation

    Time frame: At 2 years of age

    Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.

  5. Bone mineral density

    Time frame: 2 years of age

    Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Päivikki and Sakari Sohlberg Foundation, Finland
  • The Finnish Governmental Special Subsidy for Health Sciences Research
  • The Finnish Medical Association

Registry information

Acronym: VIDI

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Nov 8, 2012
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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