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The study is a parallel interventional randomized dose-response trial designed to improve vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will be recruited from the general population in the greater Montreal area. The study will be conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children will be required to attend two study visits. Some information will be collected through monthly telephone survey to the parents. The investigators will add vitamin D to cheese and yogurt for daily consumption at home over a three month period. All products will be provided to the parents in the form of coded containers that do not contain any labels aside from the group and expiration date. Ingredient lists will be provided upon consenting to the study. To better understand vitamin D status; dietary intake, hematology, serum biochemistry including 25(OH)D, growth, and body composition will be measured at the beginning and end of the three month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be documented and a skin pigmentation test will be used to more objectively assess chronic sun exposure. The investigators will also investigate the association between vitamin D intake and status with immune function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group 1 | Active Comparator | regular fortified milk + regular cheese/yogurt |
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| Intervention Group 2 | Experimental | Vitamin D fortified yogurt and cheese; vitamin D dose increment of 252 IU vs grp 1 |
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| Intervention Group 3 | Experimental | Vitamin D fortified yogurt and cheese, vitamin D dose increment of 420 IU vs grp 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D fortified yogurt and cheese products | Other |
| ||
| Control Group 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 25(OH)D serum concentrations | 12 weeks |
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Inclusion Criteria:
All races will be studied.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hope A Weiler, PhD | McGill University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26675772 | Derived | Brett NR, Lavery P, Agellon S, Vanstone CA, Maguire JL, Rauch F, Weiler HA. Dietary vitamin D dose-response in healthy children 2 to 8 y of age: a 12-wk randomized controlled trial using fortified foods. Am J Clin Nutr. 2016 Jan;103(1):144-52. doi: 10.3945/ajcn.115.115956. Epub 2015 Dec 16. |
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| Other |
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