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Trial record 29 of 33 for:    "multiple sclerosis" | "vitamin d"

Vitamin D Supplementation and Sunlight Exposure in Brazilian Women Living in Opposite Latitudes (The D-SOL Study) (D-SOL)

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ClinicalTrials.gov Identifier: NCT03318029
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Goiás
Information provided by (Responsible Party):
Marcela Moraes Mendes, University of Surrey

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D supplementation Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Prevention
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).
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Placebo UK trial
Placebo and living in the UK
Dietary Supplement: Placebo
rice flour with no vitamin D

Active Comparator: Vitamin D UK trial
Vitamin D supplementation and living in the UK
Dietary Supplement: Vitamin D supplementation
Vitamin D supplementation of 600 IU daily for 12 weeks

Placebo Comparator: Placebo Brazil Trial
Placebo and living in the Brazil
Dietary Supplement: Placebo
rice flour with no vitamin D

Active Comparator: Vitamin D Brazil Trial
Vitamin D supplementation and living in Brazil
Dietary Supplement: Vitamin D supplementation
Vitamin D supplementation of 600 IU daily for 12 weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    These will be assessed by participants use of individual sunlight dosimeters and self-reported sun exposure diary

  2. Prevalence of inadequate dietary Vitamin D intake in these women [ Time Frame: baseline ]
    These will be assessed by self-reported food diaries

  3. Baseline prevalence of insufficient/deficient levels of vitamin D in these women. [ Time Frame: baseline ]
    These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants at baseline

  4. Change in the number of participants with insufficient/deficient levels of vitamin D after intervention [ Time Frame: baseline and after 12 weeks intervention ]
    These will be assessed by measuring serum 25(OH)D (in nmol/L) levels in participants during winter (baseline and final visit)

  5. Influence of latitude on vitamin D optimal levels. [ Time Frame: baseline ]
    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)

  6. Influence of skin pigmentation on vitamin D optimal levels. [ Time Frame: baseline ]
    These will be assessed by comparing baseline measurements of serum 25(OH)D (in nmol/L) levels and self-reported skin type

  7. Vitamin D status influence on bone health [ Time Frame: baseline ]
    Elucidation of the association between Vitamin D status and markers of calcium of calcium metabolism

  8. Vitamin D supplementation response dependence on initial vitamin D levels. [ Time Frame: baseline and after 12 weeks intervention ]
    Assessed by comparing baseline and after intervention measurements of serum 25(OH)D (in nmol/L) levels.

  9. Genetic and enzymatic mechanisms underlying the response to vitamin D supplementation [ Time Frame: baseline and after 12 weeks intervention ]
    These will be assessed by genotyping for polymorphisms related to vitamin D metabolism



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Brazilian nationality Living in the UK or in Brazil for more than 2 months

Exclusion Criteria:

  • 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.

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): NCT03318029


Locations
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Brazil
Federal University of Goiás
Goiânia, Goiás, Brazil, 74605-080
United Kingdom
University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XH
Sponsors and Collaborators
University of Surrey
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Goiás
Investigators
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Study Chair: Kath Hart, Ph.D Lecturer, Department of Nutritional Sciences, University of Surrey
Study Chair: Patricia Borges Botelho, Ph.D Lecturer, Post-graduate Department of Nutrition, Federal University of Goiás
Study Chair: Laura Tripkovic, Ph.D Teaching Fellow, Department of Nutritional Sciences, University of Surrey
  Study Documents (Full-Text)

Documents provided by Marcela Moraes Mendes, University of Surrey:

Publications:
Wang 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, Järvelin MR, Karasik D, Siscovick DS, Econs MJ, Kritchevsky SB, Florez JC, Todd JA, Dupuis J, Hyppönen 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.

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Responsible Party: Marcela Moraes Mendes, PhD Research Fellow, University of Surrey
ClinicalTrials.gov Identifier: NCT03318029     History of Changes
Other Study ID Numbers: D-SOL
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcela Moraes Mendes, University of Surrey:
Vitamin D
Supplementation
Sunlight
Additional relevant MeSH terms:
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Vitamin D
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents