NCT02474446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

June 4, 2015

Last Update Submit

June 12, 2015

Conditions

Vitamin D Status

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Participants will be followed for the duration of the study, an expected average of 4 weeks

  • Change in serum calculated free vitamin D

    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.

    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

    Participants will be followed for the duration of the study, an expected average of 4 weeks

Other Outcomes (1)

  • Evidence of hypercalciuria

    Participants will be followed for the duration of the study, an expected average of 4 weeks

Study Arms (1)

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.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

150,000 IU of Vitamin D3 Oral solution

1

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young male adults aged 18 25 years
  • Free from any condition affecting bone health, general nutrition, growth and glucose metabolism.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Sujatha Gopal

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 17, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 17, 2015

Record last verified: 2015-06

Locations

GB(1)