VIDI-P: Vitamin D Intervention in Infants - Pilot
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Vitamin D3 10µg
|
Dietary Supplement: cholecalciferol (D3)
10µg (400 IU) orally daily for 10 weeks
|
| Active Comparator: Vitamin D3 30µg
|
Dietary Supplement: cholecalciferol (D3)
30µg (1200 IU) orally daily for 10 weeks
|
| Active Comparator: Vitamin D3 40µg
|
Dietary Supplement: cholecalciferol (D3)
40µg (1600 IU) orally daily for 10 weeks
|
Outcome Measures
Primary Outcome Measures
- S-25OHD concentration after vitamin D supplementation to infants [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 Outcome Measures
- concentration of calcium in the plasma and in the urine [after 10 weeks of supplementation]
Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).
- bone mineral density [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
healthy Caucasian women with an uneventful pregnancy
-
healthy infants born at term and appropriate for gestational age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Children and Adolescents, Helsinki University Central Hospital | Helsinki | Finland | 00029 |
Sponsors and Collaborators
- Helsinki University Central Hospital
- University of Helsinki
Investigators
- Principal Investigator: Sture Andersson, MD, PhD, Helsinki University Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T1040D0038
- 2009-015940-40