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

NCT03318029 | Completed

• 1 other identifier: D-SOL
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 2

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Supplementation; Sunlight

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  baseline

• Prevalence of inadequate dietary Vitamin D intake in these women

  baseline

• Baseline prevalence of insufficient/deficient levels of vitamin D in these women.

  baseline

• Change in the number of participants with insufficient/deficient levels of vitamin D after intervention

  baseline and after 12 weeks intervention

• Influence of latitude on vitamin D optimal levels.

  baseline

Study Arms (4)

Placebo UK trial

PLACEBO COMPARATOR

Placebo and living in the UK

Dietary Supplement: Placebo

Vitamin D UK trial

ACTIVE COMPARATOR

Vitamin D supplementation and living in the UK

Dietary Supplement: Vitamin D supplementation

Placebo Brazil Trial

PLACEBO COMPARATOR

Placebo and living in the Brazil

Dietary Supplement: Placebo

Vitamin D Brazil Trial

ACTIVE COMPARATOR

Vitamin D supplementation and living in Brazil

Dietary Supplement: Vitamin D supplementation

Interventions

Vitamin D supplementation DIETARY_SUPPLEMENT

Vitamin D supplementation of 600 IU daily for 12 weeks

Vitamin D Brazil Trial; Vitamin D UK trial

Placebo DIETARY_SUPPLEMENT

rice flour with no vitamin D

Placebo Brazil Trial; Placebo UK trial

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Universidade Federal de Goiás: collaborator

Study Sites (2)

Federal University of Goiás

Goiânia, Goiás, 74605-080, Brazil

Location

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (5)

• Adams JS, Hewison M. Update in vitamin D. J Clin Endocrinol Metab. 2010 Feb;95(2):471-8. doi: 10.1210/jc.2009-1773.

  PMID: 20133466 BACKGROUND

• Bandeira 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.

  PMID: 20485913 BACKGROUND

• Lips 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.

  PMID: 11493580 BACKGROUND

• 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, 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.

  PMID: 20541252 BACKGROUND

• Mendes 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.

  PMID: 34255034 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 23, 2017
• Study Start: October 1, 2016
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: October 23, 2017

Record last verified: 2017-10

Locations

BR (1); GB (1)