Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
Status:
Unknown status
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
Abstract Background: Vitamin D affects a wide variety of functions in the body including
regulation of calcium, phosphorus, and bone metabolism. Israeli studies have documented a
high prevalence of Vitamin D deficiency in Israeli infants in general, which was more severe
in infants from Ultra-Orthodox Jewish families. Modest dress requirements in this population
drastically reduce sun exposure, known to encourage production of Vitamin D. Countless
research has analyzed preterm as well as term neonates born to mothers with vitamin D
deficiency, with regard to weight, height, and bone mineral density at birth. However, there
is a paucity of information about healthy infants' vitamin D levels and its' correlation to
these parameters during the first few years of life. Objectives: The purpose of the proposed
study is to measure and correlate levels of 25(OH)D and bone mineral density towards the end
of the first year of life with growth rates and bone mineral density in the same children at
the ages of 2, 3 and 5 years. Patients and Methods: The study will be performed in the
Ultra-Orthodox Jewish community of Beitar Illit. 25(OH)D levels will be taken between 9-12
months of age (when routine blood tests are normally drawn for these infants) and bone
mineral density will be measured using Quantitative Ultrasound. Infants will be divided into
2 groups: those with those with normal 25(OH)D levels (>15ng/ml), and those with 25(OH)D
deficiency (<15ng/ml). Group 1- normal levels will receive no intervention. Infants with
25(OH)D below 15ng/ml will be randomly assigned into one of two groups; Group 2-those
receiving continued vitamin D supplementation of 800 international units(IU) (4gtt/d) for one
year, or Group 3- those receiving the placebo. Height, weight, and head circumference growth
curves will be recorded every two months until 2 years of age. Quantitative ultrasound,
growth charts and blood tests including 25(OH)D, serum calcium and phosphate levels,
Parathyroid hormone (PTH), and alkaline phosphatase, taken at approximately 9-12 months will
be repeated at 2 years of age. At that time children from Group 1 (no supplementation) will
be divided into three: Group 1a- normal 25(OH)D levels will continue with no intervention,
Group 1b <15ng/ml will begin receiving vitamin D 4gtt/d, Group 1c <15ng/ml will receive a
placebo until age three. Groups 2 and 3 will continue their previous treatment until age
three. All aforementioned tests will be repeated at age 3, when treatment will stop, and the
same tests will be repeated at age 5.