Hypovitaminosis D in healthy subjects / Subclinical vitamin D deficiency. Recently there have been many reports of vitamin D deficiency in healthy adolescents worldwide. It is not yet known whether this (if uncorrected) has any long term detrimental effects on bone health. Vitamin D is essential for calcium absorption which is required for bone growth.
Conditions
Interventions
Trade Name: Ergocalciferol Tablets BP 1.25 mg
Product Name: Ergocalciferol
Pharmaceutical Form: Tablet
INN or Proposed INN: Ergocalciferol BP 1.25 mg ta
Sponsors
R & D Directorate,Central Manchester and Manchester Children's University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy post-menarchal adolescent girls aged between 12 to 14 years. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Girls with chronic disease (especially liver or kidney problems) or those taking medication affecting bone health will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether vitamin D supplementation to healthy vitamin D deficient girls results in greater bone mass accumulation when compared with their placebo controlled counterparts .; Secondary Objective: To determine whether vitamin D status during puberty has any relationship with ; 1) Muscle strength ; 2)Body stores of Iron; 3)Quantitative ultrasound bone measurements. ; Primary end point(s): 1)Increase in bone mineral density and bone mineral content over the 12 month study period; 2)Change in body iron stores following administration of vitaminD/Placebo. | — |
Countries
United Kingdom
Outcome results
None listed