Prevention of Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency

Detailed Description
-----------------
It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably. The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight >2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.

Official Title
-----------------
Prevention of Vitamin D Deficiency in Breastfed Infants

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infant No major congenital malformations Less than one month old Breastfed, no other foods Exclusion Criteria: Formula feeding Premature birth

Ages Eligible for Study
-----------------
Minimum Age: 3 Weeks
Maximum Age: 5 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 200 IU/day Vitamin D<br>200 IU/day Vitamin D | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day<br>* Infants receive daily 0.5 ml of code labeled supplement<br>|
| Experimental: 400 IU/day Vitamin D<br>400 IU/day Vitamin D | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day<br>* Infants receive daily 0.5 ml of code labeled supplement<br>|
| Experimental: 600 IU/day Vitamin D<br>600 IU/day Vitamin D | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day<br>* Infants receive daily 0.5 ml of code labeled supplement<br>|
| Experimental: 800 IU/day Vitamin D<br>800 IU/day Vitamin D | Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day<br>* Infants receive daily 0.5 ml of code labeled supplement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase |  | end of winter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body mineral content by DEXA |  | end of winter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D deficiency, breastfed infant, northern latitude, infant, breastfed, winter, vitamin D status