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Getting Vitamin D Dosing Right

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ClinicalTrials.gov Identifier: NCT02474446
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Vitamin D Status Dietary Supplement: Vitamin D Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determining the Effects of Race, Skin Colour and Genotype on the Response to Vitamin D Therapy
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 1

Anthropometry measurement, Skin colour grading using Fitzpatrick scale, Dietary intake of calcium and vitamin D using food frequency questionnaire (FFQ), Baseline fasting blood samples for vitamin D, VDBP, VDBP genotype, Calcium, Phosphorus, Albumin, Parathyroid Hormone(PTH), Alkaline Phosphatase, Bone turnover markers(P1NP, CTX).

Fasting urine for Calcium Creatinine ratio. Saliva for bio-available Free Vitamin D measurement.

Vitamin D administration under direct supervision. Spot Urine sample for calcium : creatinine ratio after a week. Repeat all measurements done at baseline except VDBP genotype 4 weeks from baseline.

Dietary Supplement: Vitamin D
150,000 IU of Vitamin D3 Oral solution




Primary Outcome Measures :
  1. Increase in serum 25 hydroxyvitaminD (25OHD) levels [ Time Frame: 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 Outcome Measures :
  1. Determine if dark skin colour or South Asian heritage reduces the increase in serum 25OHD. [ Time Frame: 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.


  2. Change in serum calculated free vitamin D [ Time Frame: 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.


  3. Determine if variation in Group specific component(GC) genotype is associated with variation in the increase in serum 25OHD. [ Time Frame: 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

  4. Determine the extent of parathyroid hormone (PTH) suppression in relation to overall increases in total and free serum 25OHD [ Time Frame: 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 Outcome Measures:
  1. Evidence of hypercalciuria [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474446


Locations
United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Investigators
Principal Investigator: Sujatha Gopal Investigator

Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02474446     History of Changes
Other Study ID Numbers: SCH/14/053
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents