Vitamin D Intervention in Infants - Pilot

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vitamin D Intervention in Infants - Pilot

Conditions
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Vitamin D, Supplementation

Intervention / Treatment
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* Dietary Supplement: cholecalciferol (D3)
* Dietary Supplement: cholecalciferol (D3)
* Dietary Supplement: cholecalciferol (D3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy Caucasian women with an uneventful pregnancy healthy infants born at term and appropriate for gestational age
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D3 10µg<br> | Dietary Supplement: cholecalciferol (D3)<br>* 10µg (400 IU) orally daily for 10 weeks<br>|
| Active Comparator: Vitamin D3 30µg<br> | Dietary Supplement: cholecalciferol (D3)<br>* 30µg (1200 IU) orally daily for 10 weeks<br>|
| Active Comparator: Vitamin D3 40µg<br> | Dietary Supplement: cholecalciferol (D3)<br>* 40µg (1600 IU) orally daily for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S-25OHD concentration after vitamin D supplementation to infants | 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. | after 10 weeks of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of calcium in the plasma and in the urine | Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). | after 10 weeks of supplementation | 
| bone mineral density | Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). | after 10 weeks of supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecalciferol, infant, bone mineral density