Vitamin D Status
Conditions
Brief summary
The investigators want to make sure that people get the right dose of Vitamin D treatment. They will therefore investigate how skin colour, body mass index, ethnicity, vitamin D binding protein and genetic variation affect the response to a standard course of vitamin D in young adults, as a prelude to further studies in younger children.
Detailed description
The Department of Health and the Chief Medical Officer have identified vitamin D deficiency as a key area of interest and concern for public health. The main function of vitamin D is to enable dietary calcium to be absorbed from the intestine. Low levels of vitamin D can lead to diseases of bone such as rickets and osteomalacia and are linked to a higher risk of fracturing bones in older women with osteoporosis. Vitamin D levels may be affected by the skin colour, body mass index (BMI), lifestyle or environment in which someone lives, and by their genetic makeup. Vitamin D levels tend to be lower in people with higher BMI and / or darker coloured skin or if the skin is covered by clothing because a lot of vitamin D is made from the action of sunlight on natural chemicals in the skin. Vitamin D does occur naturally in the diet in foods like oily fish, and also vitamin D can be given as a supplement either on its own or as part of a multivitamin tablet. There is natural variation from one person to another in how well the system controlling vitamin D blood levels works. Vitamin D circulates bound to a carrier protein, vitamin D binding protein (VDBP). When vitamin D levels are measured, both vitamin D bound to the protein and free vitamin D are measured. A recent study in America showed that when free vitamin D levels (total vitamin D minus vitamin D bound to VDBP) are measured, they correlate very closely with other factors that help determine blood calcium levels.This variation is determined in part by a person's genetic makeup, and recent large studies have identified specific genetic variations that are linked to blood levels of vitamin D; some of these vary with the person's ethnic origin. At present if someone has low vitamin D levels that put them at increased risk of bone problems, a course of vitamin D treatment is given. When the investigators assessed their regular treatment given to children recently, they found some individuals developed very high blood vitamin D levels and others didn't. They don't know how VDBP levels affect the response to treatment with vitamin D. Further variation can occur because of the distribution of vitamin D into fat tissue. The investigators will measure height and weight, and waist and hip circumference and calculate Body Mass Index, body surface area (BSA) and waist: hip ratio as proxy measures of fat mass. They will also evaluate whether blood or saliva tests give better information about vitamin D levels. The information about how these factors affect the response to vitamin D will help the clinicians choose the right dose of vitamin D for studies in younger children who are still growing.
Interventions
150,000 IU of Vitamin D3 Oral solution
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy young male adults aged 18 25 years * Free from any condition affecting bone health, general nutrition, growth and glucose metabolism.
Exclusion criteria
* Subjects with any chronic illness involving the liver and kidney * Use of steroids, anticonvulsants or any medication that might affect calcium and vitamin D metabolism. * Potential participants who have made plans to travel abroad during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in serum 25 hydroxyvitaminD (25OHD) levels | Participants will be followed for the duration of the study, an expected average of 4 weeks | Increase in serum 25OHD levels by at least 25 nmol/L in the majority of the participants, 4 weeks after administration of 150,000 units of vitamin D, according to genotype and ethnicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine if dark skin colour or South Asian heritage reduces the increase in serum 25OHD. | Participants will be followed for the duration of the study, an expected average of 4 weeks | Change in serum 25OHD 4 weeks after dosing with 150,000 international units(IU) of Vitamin D according to skin colour Change in urinary calcium:creatinine ratio at 1 week after dosing. Change in in serum calculated free vitamin D, calcium, PTH and alkaline phosphatase 4 weeks after dosing. |
| Change in serum calculated free vitamin D | Participants will be followed for the duration of the study, an expected average of 4 weeks | Change in calculated 'free' 25OHD 4 weeks after dosing with 150,000IU of Vitamin D Change in urinary calcium:creatinine ratio at 1 week after dosing. Change in in serum calculated free vitamin D, calcium, PTH and alkaline phosphatase 4 weeks after dosing. |
| Determine if variation in Group specific component(GC) genotype is associated with variation in the increase in serum 25OHD. | Participants will be followed for the duration of the study, an expected average of 4 weeks | Change in serum 25OHD levels according to GC Genotype |
| Determine the extent of parathyroid hormone (PTH) suppression in relation to overall increases in total and free serum 25OHD | Participants will be followed for the duration of the study, an expected average of 4 weeks | Extent of PTH suppression before and after dosing with 150,000IU of Vitamin D |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evidence of hypercalciuria | Participants will be followed for the duration of the study, an expected average of 4 weeks | Spot urine calcium:creatinine ratio will be performed on second void fasting urine 1 week after dosing to reassure that no hypercalciuria has occurred in any subject. |
Countries
United Kingdom