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Completed

NCT Number: NCT01275885

Vitamin D Intervention in Infants - Pilot

The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.

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Key information

Conditions

Vitamin D Supplementation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Children and Adolescents, Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy Caucasian women with an uneventful pregnancy
  • healthy infants born at term and appropriate for gestational age

Treatment and study plan

cholecalciferol (D3)

Dietary Supplement

10µg (400 IU) orally daily for 10 weeks

Primary outcomes

  1. S-25OHD concentration after vitamin D supplementation to infants

    Time frame: after 10 weeks of supplementation

    The primary endpoint is the concentration of 25OHD in serum after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). Vitamin D supplementation is given to infants from 2 weeks of age to 3 months of age.

Secondary outcomes

  1. concentration of calcium in the plasma and in the urine

    Time frame: after 10 weeks of supplementation

    Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).

  2. bone mineral density

    Time frame: after 10 weeks of supplementation

    Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Acronym: VIDI-P

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2011
Registry last updated
Jul 18, 2011

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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