Vitamin D Supplementation in Younger Women
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      That on average it will require a vitamin D dose of 1700IU/day to increase the serum
      25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to
      2480 IU/day in African American
    

Detailed description: 
      Vitamin D is a unique nutrient in that its requirement can be met by both endogenous
      production from sun and from diet, which makes it difficult to determine the actual
      requirements as for other nutrients. The current recommended dietary reference intake (DRI)
      for vitamin D is 200 IU for adults between 25- 50 years, 400 IU for adults between 51-70
      years and 600 IU for adults 70 years of age. In view of many scientists in the field of
      vitamin D, the current DRI of vitamin D is too low. This is mainly because of the increase in
      prevalence of vitamin D deficiency observed in the population based on measured serum 25OHD
      levels. It is now recognized that serum 25OHD is an indicator of vitamin D status. There is a
      growing consensus that serum 25OHD concentration of at least 30-32 ng/ml are needed to reduce
      serum Parathyroid hormone (PTH) and reduce bone loss. Also, research over the last two
      decades has provided additional evidence that higher vitamin D levels (25OHD 30ng/ml) are
      necessary for optimum overall health and prevent disease. There is no clear view of the
      amount of vitamin D intake required to maintain the optimum level of serum 25OHD levels in
      the population of all ages and there are no systematic dose response studies of vitamin D in
      women of all ages. A few studies carried out with different sexes and age groups have
      suggested that an untreated subject with a serum 25OHD concentration of 20 ng/ml would need a
      daily dose of ~1700 IU/d of Vitamin D3 to reach a serum 25OHD of 32 ng/ml in Caucasians,
      while in African Americans the Vitamin D3 requirement would be higher - 1860-2480 IU/d.

      The current proposal aims at studying the dose response effect of vitamin D3 400 IU, 800
      IU,1600 IU and 2400 IU or placebo on serum 25OHD and serum PTH in young women with vitamin D
      insufficiency (serum 25OHD <20 ng/ml) and an adequate calcium intake of 1000mg/day.

      Another aim of the study is to establish the minimum effective dose of vitamin D3 which
      Normalizes PTH in Caucasian and African American young women. Vitamin D dose that reduces
      serum PTH to normal level in 97% of normal population is the recommended dietary allowance.

      We will also establish the safety of these higher doses of vitamin D supplementation relating
      to hypercalcemia/hypercalcuria.
    

Intervention name(s): vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1000-1200 mg/day
Other intervention name(s): Calcium citrate (Citracal)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Vitamin D insufficiency,vitamin D3 treatment,young women