Tufts University
Boston, Massachusetts, 02111, United States
NCT Number: NCT01537809
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
Looking for future studies?
Notify Me9 year–14 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects are told to take vitamin D daily for 6 months.
Time frame: Six months
Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months.
Safety Issue?: (FDAAA) No
Time frame: 12 months
Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months
Tufts University
Other
The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
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.
Published trials that share one or more normalized conditions with this study.
NCT04170348
Acute Chest Syndrome, Anemia
New York, United States
View Trial DetailsNCT06870786
Avitaminosis, Deficiency Diseases
Bolu, Turkey (Türkiye)
View Trial DetailsNCT01909063
Avitaminosis, Deficiency Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07631312
Anemia, Anemia, Hypochromic
Atlanta, Georgia, United States
View Trial Details