Vitamin D DeficiencyD-SOLNCT03318029
Vitamin D Supplementation and Sunlight Exposure in Brazilian Women Living in Opposite Latitudes (The D-SOL Study)
A study testing Vitamin D supplementation in people with Vitamin D Deficiency, run by University of Surrey at 2 sites in 2 countries.
Trial summary
There is a consensus that vitamin D deficiency is a public health issue because of its implications in several diseases including, osteopenia, osteomalacia, heart disease, diabetes (type I and II), inflammatory diseases, multiple sclerosis and rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2016to 25 Sep 2017
- 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 20 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Brazilian nationality Living in the UK or in Brazil for more than 2 months
Who cannot join
- Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism ( osteoporosis therapy, anti-estrogens treatment, antiepileptic drugs, breast-cancer treatment)
- Hypercalcaemia (>2.5mmol/L) - assessed and excluded at baseline
- Regular use of sun-beds
- Having a holiday trip for more than 4 weeks, one month prior to commencing the study or plans for a holiday trip out of the country of residence within the study period.
- Use of vitamin supplements containing vitamin D (if the prospective participants agrees to stop Vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable).
- Pregnant or planning a pregnancy during the study period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Systems Biology Approach to the Interaction Between Vitamin D Supplementation and Sunlight Exposure in Brazilian Women Living in Opposite Latitudes (The D-SOL Study).
There is a consensus that vitamin D deficiency is a public health issue because of its implications in several diseases including, osteopenia, osteomalacia, heart disease, diabetes (type I and II), inflammatory diseases, multiple sclerosis and rheumatoid arthritis. Studies in sunny countries have shown that vitamin D deficiency is a common phenomenon, despite the abundance of sunlight in these places, which shows the influence of diet, skin pigmentation, cultural habits and also genetic factors on the metabolism of this vitamin. Thus, the study hypothesis is that vitamin D supplementation is required to obtain the optimal serum concentration in Brazilian people living both in Brazil and in the United Kingdom and that this response is dependent on the initial levels, being influenced by sunlight exposure, skin pigmentation, diet and polymorphisms of the vitamin D receptor gene. Two controlled, randomized, double-blind clinical trials were held (one in the UK and the other in Brazil) over a period of 12 weeks, with female subjects, Brazilian, aged 20 to 59 years. The women selected were divided into two groups: Placebo Group and Supplemented Group, the latter received vitamin D 600 IU. After the analysis of the effect of vitamin D supplementation compared to placebo, the investigators propose to analyse genome-wide transcriptomic expression in order to associate specific signal transduction and metabolic pathways to respective vitamin D responses. and a genetic risk score based on polymorphisms will be constructed. The 'systems level' approach will enable us to identify differences in gene expression and whether this explains why some individuals are 'good' responders or 'poor' responders to vitamin D supplementation. This is the first study that will examine two population groups of the same ethnic group and sex, living in different countries, with identical design studies. Our results first will determine how important supplementation and exposure to sunlight are for the serum level of vitamin D by comparing directly, using the same methodology, people living in different latitudes, as well as the genetic influence on the response to supplementation. The data will also provide both countries key data about the need to reconsider new revisions to dietary recommendations for vitamin D in adults.
Read the detailed description
During this study the subjects were asked to visit the Clinical Investigation Unit, FHMS, University of Surrey in the UK or the Research Clinic, Faculty of Nutrition, Federal University of Goiás in Brazil, on two occasions, at the beginning of the study for baseline measurements and at the conclusion of the study. The investigators examined four to eight fasted subjects per study morning. Trial visits lasted approximately 45-60 minutes each and took place in the morning (7am-11am). Participants were offered refreshments at the end of their appointment.
If participants wished to be screened for participation in the study, they would receive the Participant Information Sheet and then be checked against the study inclusion and exclusion criteria using a 'Screening Questionnaire' , administered by a member of the D-SOL Research Team by phone or self-reported by email.
Baseline visit:
If eligible, participants were invited for the baseline visit. At this visit, they were first given time to discuss the Participant Information Sheet and any questions they may have regarding the study. Informed consent was discussed and participants were asked to sign the consent form, and offered a copy to keep for themselves.
Baseline procedures:
- Health and Lifestyle questionnaire administered by a member of the D-SOL Research Team.
- Anthropometrics and blood pressure measured, and fasted blood sample taken (serum 25OHD levels, 1,25-dihydroxy vitamin D, serum calcium, albumin, parathyroid hormone, C-terminal telopeptide (CTX) ≈25ml) with an additional ≈10 ml for genetic profiling and ≈15 for storage for future measurements of nutritional markers.
- pQCT scan of the non-dominant forearm (UK trial) or dual energy x-ray absorptiometry (DEXA) scan (Brazil trial).
- Bioelectrical impedance analysis (BIA) for body composition.
- Provision of randomly assigned daily supplement (30 days' supply), food diaries and sunlight dosimeters and sunlight exposure diary to be returned at 12 week visit. Follow-up appointment details arranged.
Final visit
- Final adverse event/compliance interview completed with investigator.
- Daily outdoor exposure diary, food diary and sunlight dosimeter received from participant and checked for consistency at visit.
- Anthropometrics and blood pressure measured, and blood sample taken (serum 25OHD levels, 1,25-dihydroxy vitamin D, serum calcium, albumin, parathyroid hormone, C-terminal telopeptide (CTX) ≈25ml) with an additional ≈10 ml for genetic profiling and ≈15 for storage for future measurements of nutritional markers.
- Bioelectrical impedance analysis (BIA) for body composition.
DNA profiling procedure - After 12 weeks: Selection of participant samples encompassing the best and worst supplementation-responders in each group, subject to previous consent form singed by participant. Vitamin D related genes will be genotyped in DNA isolated from the study blood samples, DNA will be extracted and vitamin D polymorphisms will be determined by University of Surrey's genetic labs.
A trained phlebotomist took the blood samples required as part of the trial protocol. Medical cover was available at all times.
Throughout the duration of the trial, the participants were contacted via telephone on a fortnightly basis to discuss any issues with any adverse event and compliance and to maintain good communication with the participants. In the case of a serious adverse event (SAE) this would be recorded and reported it to both the Sponsor (University of Surrey) and the Surrey Ethics Committee.
The final interview was completed at the final study visit. Participants have also been asked to return any supplements that were missed to confirm compliance.
For University of Surrey participants: A peripheral quantitative computed tomography (pQCT) scan was performed on the participant's non-dominant forearm at the baseline visit, to measure volumetric bone mineral density at the 4% and 66% radial site. This will allow for separate measurements of trabecular volumetric bone mineral density (vBMD) and trabecular area (4% site) and cortical vBMD and cortical area (66% site), as well as strength strain index, a measure of bone strength. pQCT also measures bone geometry alongside bone density. Therefore the muscle cross sectional area can be determined, which is a measure of muscle force, to which bone strength is adapted to. One scan was performed at baseline only and effective exposure doses were between ~1.5-1.8uSv.
For Federal University of Goiás participants: Body composition (absolute and relative amount of lean and fat mass), whole body mineral density and lower spine and femur bone mineral density was measured with the use of DEXA (located at the Nutrition Clinic based at the Federal University of Goiás), at baseline only. Two scans were performed at baseline for each participant: one to assess the whole body mineral density and body composition, and the other to specifically assess fracture risk by scanning the spine and femoral head. Effective exposure doses for theses scans are ~8uSv and ~4uSv respectively.
Results of the body composition, vitamin D status and dietary intake from the self-reported food diaries will be made available to the subjects upon request. The results from the blood analysis will be reported to the subject if there are any health concerns raised. If the results are within healthy ranges the participants will not be contacted unless they specifically request for this information. The investigators will not be contacting their general practitioner (GP) if there are any concerns raised in the study however the investigators will stress that they should contact their GP themselves to discuss the results.
The trial was conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004 and Amended Regulations 2006.
Detailed protocol and supporting documents were submitted for review by the University of Surrey Ethics Committee and the Federal University of Goiás, Brazil. The study received favourable ethical opinion from both Committees prior to commencing the study. Annual progress reports and a final report will be submitted to the ethics committees as defined in their respective regulations.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D supplementation, Placebo
- Keywords
- Vitamin D, Supplementation, Sunlight
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationDietary supplement
Vitamin D supplementation of 600 IU daily for 12 weeks
PlaceboDietary supplement
rice flour with no vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Placebo UK trial | Placebo comparator | Placebo and living in the UK Receives: Dietary Supplement: Placebo |
| Vitamin D UK trial | Active comparator | Vitamin D supplementation and living in the UK Receives: Dietary Supplement: Vitamin D supplementation |
| Placebo Brazil Trial | Placebo comparator | Placebo and living in the Brazil Receives: Dietary Supplement: Placebo |
| Vitamin D Brazil Trial | Active comparator | Vitamin D supplementation and living in Brazil Receives: Dietary Supplement: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline vitamin D status at 12 weeks of vitamin D supplementation
These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants at baseline and 12 weeks
Measured: baseline and 12 weeks
Secondary outcomes (9)
Analyze the difference regarding time and intensity of sun exposure between Brazilian women living in Brazil and Brazilian women living in the UK.
These will be assessed by participants use of individual sunlight dosimeters and self-reported sun exposure diary
Measured: baseline
Prevalence of inadequate dietary Vitamin D intake in these women
These will be assessed by self-reported food diaries
Measured: baseline
Baseline prevalence of insufficient/deficient levels of vitamin D in these women.
These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants at baseline
Measured: baseline
Change in the number of participants with insufficient/deficient levels of vitamin D after intervention
These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants during winter (baseline and final visit)
Measured: baseline and after 12 weeks intervention
Influence of latitude on vitamin D optimal levels.
These will be assessed by comparing measurements of serum 25(OH)D (in nmol/L) levels in participants at baseline between women living in the UK (latitude 51 North) and those living in Brazil (latitude 16 South)
Measured: baseline
Influence of skin pigmentation on vitamin D optimal levels.
These will be assessed by comparing baseline measurements of serum 25(OH)D (in nmol/L) levels and self-reported skin type
Measured: baseline
Vitamin D status influence on bone health
Elucidation of the association between Vitamin D status and markers of calcium of calcium metabolism
Measured: baseline
Vitamin D supplementation response dependence on initial vitamin D levels.
Assessed by comparing baseline and after intervention measurements of serum 25(OH)D (in nmol/L) levels.
Measured: baseline and after 12 weeks intervention
Genetic and enzymatic mechanisms underlying the response to vitamin D supplementation
These will be assessed by genotyping for polymorphisms related to vitamin D metabolism
Measured: baseline and after 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Oct 2016
- Primary completion25 Sep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two controlled, randomized, double-blind clinical trials developed and undertaken (one in Brazil and the other in the UK) with an intervention period of 12 weeks. The women selected were randomly divided into two groups: Placebo Group and Supplemented Group, the latter will receive 600UI of vitamin D, in each country. Groups (arms): Placebo UK trial; Vitamin D UK trial; Placebo Brazuk trial; Vitamin D Brazil trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Goiás
- Responsible party
- Principal investigator, Marcela Moraes Mendes, University of Surrey
- Investigators
- Kath Hart, Ph.D, Study chair, Lecturer, Department of Nutritional Sciences, University of SurreyPatricia Borges Botelho, Ph.D, Study chair, Lecturer, Post-graduate Department of Nutrition, Federal University of GoiásLaura Tripkovic, Ph.D, Study chair, Teaching Fellow, Department of Nutritional Sciences, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318029
- Sponsor's protocol ID
- D-SOL
- Acronym
- D-SOL
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adams JS, Hewison M. Update in vitamin D. J Clin Endocrinol Metab. 2010 Feb;95(2):471-8. doi: 10.1210/jc.2009-1773.
PubMed 20133466Bandeira F, Griz L, Freese E, Lima DC, The AC, Diniz ET, Marques TF, Lucena CS. Vitamin D deficiency and its relationship with bone mineral density among postmenopausal women living in the tropics. Arq Bras Endocrinol Metabol. 2010 Mar;54(2):227-32. doi: 10.1590/s0004-27302010000200020.
PubMed 20485913Lips P. Vitamin D deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev. 2001 Aug;22(4):477-501. doi: 10.1210/edrv.22.4.0437.
PubMed 11493580Wang TJ, Zhang F, Richards JB, Kestenbaum B, van Meurs JB, Berry D, Kiel DP, Streeten EA, Ohlsson C, Koller DL, Peltonen L, Cooper JD, O'Reilly PF, Houston DK, Glazer NL, Vandenput L, Peacock M, Shi J, Rivadeneira F, McCarthy MI, Anneli P, de Boer IH, Mangino M, Kato B, Smyth DJ, Booth SL, Jacques PF, Burke GL, Goodarzi M, Cheung CL, Wolf M, Rice K, Goltzman D, Hidiroglou N, Ladouceur M, Wareham NJ, Hocking LJ, Hart D, Arden NK, Cooper C, Malik S, Fraser WD, Hartikainen AL, Zhai G, Macdonald HM, Forouhi NG, Loos RJ, Reid DM, Hakim A, Dennison E, Liu Y, Power C, Stevens HE, Jaana L, Vasan RS, Soranzo N, Bojunga J, Psaty BM, Lorentzon M, Foroud T, Harris TB, Hofman A, Jansson JO, Cauley JA, Uitterlinden AG, Gibson Q, Jarvelin MR, Karasik D, Siscovick DS, Econs MJ, Kritchevsky SB, Florez JC, Todd JA, Dupuis J, Hypponen E, Spector TD. Common genetic determinants of vitamin D insufficiency: a genome-wide association study. Lancet. 2010 Jul 17;376(9736):180-8. doi: 10.1016/S0140-6736(10)60588-0. Epub 2010 Jun 10.
PubMed 20541252Mendes MM, Hart KH, Williams EL, Mendis J, Lanham-New SA, Botelho PB. Vitamin D Supplementation and Sunlight Exposure on Serum Vitamin D Concentrations in 2 Parallel, Double-Blind, Randomized, Placebo-Controlled Trials. J Nutr. 2021 Oct 1;151(10):3137-3150. doi: 10.1093/jn/nxab209.
PubMed 34255034
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systems Biology Approach to the Interaction Between Vitamin D Supplementation and Sunlight Exposure in Brazilian Women Living in Opposite Latitudes (The D-SOL Study).
- ClinicalTrials.gov ID
- NCT03318029
- Acronym / sponsor ID
- D-SOL / D-SOL
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Supplementation, Sunlight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Universidade Federal de Goiás
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
There is a consensus that vitamin D deficiency is a public health issue because of its implications in several diseases including, osteopenia, osteomalacia, heart disease, diabetes (type I and II), inflammatory diseases, multiple sclerosis and rheumatoid arthritis. Studies in sunny countries have shown that vitamin D deficiency is a common phenomenon, despite the abundance of sunlight in these places, which shows the influence of diet, skin pigmentation, cultural habits and also genetic factors on the metabolism of this vitamin. Thus, the study hypothesis is that vitamin D supplementation is required to obtain the optimal serum concentration in Brazilian people living both in Brazil and in the United Kingdom and that this response is dependent on the initial levels, being influenced by sunlight exposure, skin pigmentation, diet and polymorphisms of the vitamin D receptor gene. Two controlled, randomized, double-blind clinical trials were held (one in the UK and the other in Brazil) over a period of 12 weeks, with female subjects, Brazilian, aged 20 to 59 years. The women selected were divided into two groups: Placebo Group and Supplemented Group, the latter received vitamin D 600 IU. After the analysis of the effect of vitamin D supplementation compared to placebo, the investigators propose to analyse genome-wide transcriptomic expression in order to associate specific signal transduction and metabolic pathways to respective vitamin D responses. and a genetic risk score based on polymorphisms will be constructed. The 'systems level' approach will enable us to identify differences in gene expression and whether this explains why some individuals are 'good' responders or 'poor' responders to vitamin D supplementation. This is the first study that will examine two population groups of the same ethnic group and sex, living in different countries, with identical design studies. Our results first will determine how important supplementation and exposure to sunlight are for the serum level of vitamin D by comparing directly, using the same methodology, people living in different latitudes, as well as the genetic influence on the response to supplementation. The data will also provide both countries key data about the need to reconsider new revisions to dietary recommendations for vitamin D in adults.
Detailed description
During this study the subjects were asked to visit the Clinical Investigation Unit, FHMS, University of Surrey in the UK or the Research Clinic, Faculty of Nutrition, Federal University of Goiás in Brazil, on two occasions, at the beginning of the study for baseline measurements and at the conclusion of the study. The investigators examined four to eight fasted subjects per study morning. Trial visits lasted approximately 45-60 minutes each and took place in the morning (7am-11am). Participants were offered refreshments at the end of their appointment.
If participants wished to be screened for participation in the study, they would receive the Participant Information Sheet and then be checked against the study inclusion and exclusion criteria using a 'Screening Questionnaire' , administered by a member of the D-SOL Research Team by phone or self-reported by email.
Baseline visit:
If eligible, participants were invited for the baseline visit. At this visit, they were first given time to discuss the Participant Information Sheet and any questions they may have regarding the study. Informed consent was discussed and participants were asked to sign the consent form, and offered a copy to keep for themselves.
Baseline procedures:
- Health and Lifestyle questionnaire administered by a member of the D-SOL Research Team.
- Anthropometrics and blood pressure measured, and fasted blood sample taken (serum 25OHD levels, 1,25-dihydroxy vitamin D, serum calcium, albumin, parathyroid hormone, C-terminal telopeptide (CTX) ≈25ml) with an additional ≈10 ml for genetic profiling and ≈15 for storage for future measurements of nutritional markers.
- pQCT scan of the non-dominant forearm (UK trial) or dual energy x-ray absorptiometry (DEXA) scan (Brazil trial).
- Bioelectrical impedance analysis (BIA) for body composition.
- Provision of randomly assigned daily supplement (30 days' supply), food diaries and sunlight dosimeters and sunlight exposure diary to be returned at 12 week visit. Follow-up appointment details arranged.
Final visit
- Final adverse event/compliance interview completed with investigator.
- Daily outdoor exposure diary, food diary and sunlight dosimeter received from participant and checked for consistency at visit.
- Anthropometrics and blood pressure measured, and blood sample taken (serum 25OHD levels, 1,25-dihydroxy vitamin D, serum calcium, albumin, parathyroid hormone, C-terminal telopeptide (CTX) ≈25ml) with an additional ≈10 ml for genetic profiling and ≈15 for storage for future measurements of nutritional markers.
- Bioelectrical impedance analysis (BIA) for body composition.
DNA profiling procedure - After 12 weeks: Selection of participant samples encompassing the best and worst supplementation-responders in each group, subject to previous consent form singed by participant. Vitamin D related genes will be genotyped in DNA isolated from the study blood samples, DNA will be extracted and vitamin D polymorphisms will be determined by University of Surrey's genetic labs.
A trained phlebotomist took the blood samples required as part of the trial protocol. Medical cover was available at all times.
Throughout the duration of the trial, the participants were contacted via telephone on a fortnightly basis to discuss any issues with any adverse event and compliance and to maintain good communication with the participants. In the case of a serious adverse event (SAE) this would be recorded and reported it to both the Sponsor (University of Surrey) and the Surrey Ethics Committee.
The final interview was completed at the final study visit. Participants have also been asked to return any supplements that were missed to confirm compliance.
For University of Surrey participants: A peripheral quantitative computed tomography (pQCT) scan was performed on the participant's non-dominant forearm at the baseline visit, to measure volumetric bone mineral density at the 4% and 66% radial site. This will allow for separate measurements of trabecular volumetric bone mineral density (vBMD) and trabecular area (4% site) and cortical vBMD and cortical area (66% site), as well as strength strain index, a measure of bone strength. pQCT also measures bone geometry alongside bone density. Therefore the muscle cross sectional area can be determined, which is a measure of muscle force, to which bone strength is adapted to. One scan was performed at baseline only and effective exposure doses were between ~1.5-1.8uSv.
For Federal University of Goiás participants: Body composition (absolute and relative amount of lean and fat mass), whole body mineral density and lower spine and femur bone mineral density was measured with the use of DEXA (located at the Nutrition Clinic based at the Federal University of Goiás), at baseline only. Two scans were performed at baseline for each participant: one to assess the whole body mineral density and body composition, and the other to specifically assess fracture risk by scanning the spine and femoral head. Effective exposure doses for theses scans are ~8uSv and ~4uSv respectively.
Results of the body composition, vitamin D status and dietary intake from the self-reported food diaries will be made available to the subjects upon request. The results from the blood analysis will be reported to the subject if there are any health concerns raised. If the results are within healthy ranges the participants will not be contacted unless they specifically request for this information. The investigators will not be contacting their general practitioner (GP) if there are any concerns raised in the study however the investigators will stress that they should contact their GP themselves to discuss the results.
The trial was conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004 and Amended Regulations 2006.
Detailed protocol and supporting documents were submitted for review by the University of Surrey Ethics Committee and the Federal University of Goiás, Brazil. The study received favourable ethical opinion from both Committees prior to commencing the study. Annual progress reports and a final report will be submitted to the ethics committees as defined in their respective regulations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Two controlled, randomized, double-blind clinical trials developed and undertaken (one in Brazil and the other in the UK) with an intervention period of 12 weeks. The women selected were randomly divided into two groups: Placebo Group and Supplemented Group, the latter will receive 600UI of vitamin D, in each country. Groups (arms): Placebo UK trial; Vitamin D UK trial; Placebo Brazuk trial; Vitamin D Brazil trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo UK trial | Placebo comparator | Dietary Supplement: PlaceboPlacebo and living in the UK |
| Vitamin D UK trial | Active comparator | Dietary Supplement: Vitamin D supplementationVitamin D supplementation and living in the UK |
| Placebo Brazil Trial | Placebo comparator | Dietary Supplement: PlaceboPlacebo and living in the Brazil |
| Vitamin D Brazil Trial | Active comparator | Dietary Supplement: Vitamin D supplementationVitamin D supplementation and living in Brazil |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Brazilian nationality Living in the UK or in Brazil for more than 2 months
Key exclusion criteria (6 listed)
- Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism ( osteoporosis therapy, anti-estrogens treatment, antiepileptic drugs, breast-cancer treatment)
- Hypercalcaemia (>2.5mmol/L) - assessed and excluded at baseline
- Regular use of sun-beds
- Having a holiday trip for more than 4 weeks, one month prior to commencing the study or plans for a holiday trip out of the country of residence within the study period.
- Use of vitamin supplements containing vitamin D (if the prospective participants agrees to stop Vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable).
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 D supplementationVitamin D supplementation of 600 IU daily for 12 weeks | Dietary supplement | Vitamin D Brazil Trial, Vitamin D UK trial |
| Placeborice flour with no vitamin D | Dietary supplement | Placebo Brazil Trial, Placebo UK trial |
Primary outcome
Change from baseline vitamin D status at 12 weeks of vitamin D supplementation
Time frame: baseline and 12 weeks
These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants at baseline and 12 weeks
9 secondary outcomes
Analyze the difference regarding time and intensity of sun exposure between Brazilian women living in Brazil and Brazilian women living in the UK.
Time frame: baseline
Prevalence of inadequate dietary Vitamin D intake in these women
Time frame: baseline
Baseline prevalence of insufficient/deficient levels of vitamin D in these women.
Time frame: baseline
Change in the number of participants with insufficient/deficient levels of vitamin D after intervention
Time frame: baseline and after 12 weeks intervention
Influence of latitude on vitamin D optimal levels.
Time frame: baseline
Influence of skin pigmentation on vitamin D optimal levels.
Time frame: baseline
Vitamin D status influence on bone health
Time frame: baseline
Vitamin D supplementation response dependence on initial vitamin D levels.
Time frame: baseline and after 12 weeks intervention
Genetic and enzymatic mechanisms underlying the response to vitamin D supplementation
Time frame: baseline and after 12 weeks intervention
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 23 Oct 2017.
- Background: PubMed 20133466Adams JS, Hewison M. Update in vitamin D. J Clin Endocrinol Metab. 2010 Feb;95(2):471-8. doi: 10.1210/jc.2009-1773.
- Background: PubMed 20485913Bandeira F, Griz L, Freese E, Lima DC, The AC, Diniz ET, Marques TF, Lucena CS. Vitamin D deficiency and its relationship with bone mineral density among postmenopausal women living in the tropics. Arq Bras Endocrinol Metabol. 2010 Mar;54(2):227-32. doi: 10.1590/s0004-27302010000200020.
- Background: PubMed 11493580Lips P. Vitamin D deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev. 2001 Aug;22(4):477-501. doi: 10.1210/edrv.22.4.0437.
- Background: PubMed 20541252Wang TJ, Zhang F, Richards JB, Kestenbaum B, van Meurs JB, Berry D, Kiel DP, Streeten EA, Ohlsson C, Koller DL, Peltonen L, Cooper JD, O'Reilly PF, Houston DK, Glazer NL, Vandenput L, Peacock M, Shi J, Rivadeneira F, McCarthy MI, Anneli P, de Boer IH, Mangino M, Kato B, Smyth DJ, Booth SL, Jacques PF, Burke GL, Goodarzi M, Cheung CL, Wolf M, Rice K, Goltzman D, Hidiroglou N, Ladouceur M, Wareham NJ, Hocking LJ, Hart D, Arden NK, Cooper C, Malik S, Fraser WD, Hartikainen AL, Zhai G, Macdonald HM, Forouhi NG, Loos RJ, Reid DM, Hakim A, Dennison E, Liu Y, Power C, Stevens HE, Jaana L, Vasan RS, Soranzo N, Bojunga J, Psaty BM, Lorentzon M, Foroud T, Harris TB, Hofman A, Jansson JO, Cauley JA, Uitterlinden AG, Gibson Q, Jarvelin MR, Karasik D, Siscovick DS, Econs MJ, Kritchevsky SB, Florez JC, Todd JA, Dupuis J, Hypponen E, Spector TD. Common genetic determinants of vitamin D insufficiency: a genome-wide association study. Lancet. 2010 Jul 17;376(9736):180-8. doi: 10.1016/S0140-6736(10)60588-0. Epub 2010 Jun 10.
- Derived from this study: PubMed 34255034Mendes MM, Hart KH, Williams EL, Mendis J, Lanham-New SA, Botelho PB. Vitamin D Supplementation and Sunlight Exposure on Serum Vitamin D Concentrations in 2 Parallel, Double-Blind, Randomized, Placebo-Controlled Trials. J Nutr. 2021 Oct 1;151(10):3137-3150. doi: 10.1093/jn/nxab209.
- Individual participant dataSharing planned: Undecided
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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.
Kath Hart, Ph.D study chair
Lecturer, Department of Nutritional Sciences, University of Surrey
Patricia Borges Botelho, Ph.D study chair
Lecturer, Post-graduate Department of Nutrition, Federal University of Goiás
Laura Tripkovic, Ph.D study chair
Teaching Fellow, Department of Nutritional Sciences, University of Surrey
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in people with Vitamin D Deficiency, run by University of Surrey at 2 sites in 2 countries.
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 1 inclusion and 6 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, 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. Some participants in this study may receive a placebo. 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?
Change from baseline vitamin D status at 12 weeks of vitamin D supplementation (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318029, which also lists 5 linked publications.
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 23 Oct 2017.