Comparison of the bioavailability of vitamin D2 and D3
| ISRCTN | ISRCTN24666304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24666304 |
| Secondary identifying numbers | RHS00976 |
- Submission date
- 24/05/2011
- Registration date
- 02/08/2011
- Last edited
- 11/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that having enough vitamin D can help prevent against many diseases, such as heart disease, bone diseases and cancer. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. When the sun shines on our skin, a reaction in the body is triggered, producing a form of vitamin D called cholecalciferol (also called vitamin D3). Another important form of vitamin D is ergocalciferol (also called vitamin D2), which is produced in plants. Studies have shown that in the winter months, many people in the UK suffer from a lack of vitamin D (vitamin D deficiency) because of the lack of sun exposure. It can be hard to take in vitamin D in the diet, as it is not naturally present in many foods. A possible solution is to fortify food or drink with vitamin D2 or D3. The aim of this study is to find out whether the concentrations of vitamin D in the blood can be maintained by regularly consuming D2 or D3, and if one is better than the other.
Who can participate?
Healthy adults among the staff and students of King’s College London (UK).
What does the study involve?
Participants are randomly allocated into one of five groups. Participants in the first group receive sachets to make hot malted milk drinks (Horlicks) which does not have any extra ingredients (placebo). Participants in the other four groups are also given sachets to make malted milk drinks, but theirs contain additional vitamin D (5ug or 10ug of either D2 or D3). Participants in all groups are asked to drink one sachet every day for four weeks. Blood samples are taken from all participants, twice at the start of the study and then weekly over the four weeks to measure the concentration of vitamin D in the blood.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Metabolic Research Unit, King's College London (UK)
When is the study starting and how long is it expected to run for?
February 2011 to April 2011
Who is funding the study?
GlaxoSmithKline (UK)
Who is the main contact?
Professor Tom Sanders
tom.sanders@kcl.ac.uk
Contact information
Scientific
King's College London
Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk |
Study information
| Study design | Parallel randomized placebo controlled double blind design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of the bioavailability of vitamin D2 and vitamin D3 in healthy volunteers when consumed at different levels in a malt drink |
| Study hypothesis | This study will investigate whether the seasonal fall in serum serum 25-hydroxyvitamin D concentrations [25(OH)D] that occurs in the winter months can be prevented by the regular consumption of ergocalciferol or cholecalciferol in a fortified drink. Vitamin D is a determinant of calcium homeostasis and therefore changes in calcium and parathyroid hormone concentrations were also investigated. |
| Ethics approval(s) | South East London REC1 February 2011, ref: 10/H0804/91 |
| Condition | Vitamin D supplementation |
| Intervention | 1. Participants were randomly allocated to placebo or one of 4 experimental treatments of vitamin D: 1.1. 5ug cholecalciferol or 1.2. 5ug ergocalciferol or 1.3. 10ug cholecalciferol or 1.4. 10ug ergocalciferol 2. The vitamin D or placebo was administered as a malted milk drink and consumed once a day for 28 days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cholecalciferol, ergocalciferol |
| Primary outcome measure | Change in serum 25(OH)D concentrations |
| Secondary outcome measures | Change in calcium and parathyroid hormone concentrations |
| Overall study start date | 22/02/2011 |
| Overall study end date | 13/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Healthy males or females 2. Ages of 18 - 65 years |
| Participant exclusion criteria | 1. Seated blood pressure >160/105 mm Hg 2. Body Mass Index <18.5 and >35 kg/m2 3. Taking vitamin and mineral supplements (including cod-liver oil), or prescription calcium/vitamin D 4. Recent exposure to high UVB light (since 1 December 2010) 5. Intolerance to study product (lactose, milk protein) 6. Chronic renal, liver or inflammatory bowel disease 7. Diabetes 8. Unwilling to follow the protocol and/or give informed consent 9. Unwilling to restrict consumption of oily fish to no more than 2 portions of oily fish per week |
| Recruitment start date | 22/02/2011 |
| Recruitment end date | 13/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 9NH
United Kingdom
Sponsor information
Industry
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
| Website | http://www.gsk.co.uk/ |
|---|---|
"ROR" |
https://ror.org/01xsqw823 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
