Vitamin D StatusNCT02474446
Getting Vitamin D Dosing Right
A study testing Vitamin D in people with Vitamin D Status, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young male adults aged 18 25 years
- Free from any condition affecting bone health, general nutrition, growth and glucose metabolism.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Determining the Effects of Race, Skin Colour and Genotype on the Response to Vitamin D Therapy
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.
Read the 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.
- Conditions
- Vitamin D Status
- Being tested
- Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
150,000 IU of Vitamin D3 Oral solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in serum 25 hydroxyvitaminD (25OHD) levels
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.
Measured: Participants will be followed for the duration of the study, an expected average of 4 weeks
Secondary outcomes (4)
Determine if dark skin colour or South Asian heritage reduces the increase in serum 25OHD.
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.
Measured: Participants will be followed for the duration of the study, an expected average of 4 weeks
Change in serum calculated free vitamin D
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.
Measured: Participants will be followed for the duration of the study, an expected average of 4 weeks
Determine if variation in Group specific component(GC) genotype is associated with variation in the increase in serum 25OHD.
Change in serum 25OHD levels according to GC Genotype
Measured: Participants will be followed for the duration of the study, an expected average of 4 weeks
Determine the extent of parathyroid hormone (PTH) suppression in relation to overall increases in total and free serum 25OHD
Extent of PTH suppression before and after dosing with 150,000IU of Vitamin D
Measured: Participants will be followed for the duration of the study, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujatha Gopal, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474446
- Sponsor's protocol ID
- SCH/14/053
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2015
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Race, Skin Colour and Genotype on the Response to Vitamin D Therapy
- ClinicalTrials.gov ID
- NCT02474446
- Acronym / sponsor ID
- SCH/14/053
- Conditions
- Vitamin D Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Vitamin DAnthropometry 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young male adults aged 18 25 years
- Free from any condition affecting bone health, general nutrition, growth and glucose metabolism.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D150,000 IU of Vitamin D3 Oral solution | Dietary supplement | 1 |
Primary outcome
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.
4 secondary outcomes
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 calculated free vitamin D
Time frame: Participants will be followed for the duration of the study, an expected average of 4 weeks
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
Related trials for Vitamin D Status
Enrolling by invitationObservational study
Vitamin D Status and Its Influencing Factors in Zhejiang Province: A Multicenter Cross-Sectional Study
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Recruiting
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Vitamin D 25-Hydroxylase Deficiency, Undernutrition
Recruiting
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
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Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
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Not yet recruitingObservational study
Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujatha Gopal principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Status, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.