Reference Interval of Vitamin D of Coastal Fishermen in Cox's Bazar District of Bangladesh

NCT04986319 | Completed

• 1 other identifier: BADAS-ERC/EC/21/00310
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 2

Brief Summary

Lack of adequate sun exposure due to urbanization is prone to hypovitaminosis D. Vitamin D (25-hydroxyvitamin D) deficiency is now a major health concern in the western world. Recent data suggest that Vitamin D level in the Bangladeshi population is also very low. However, the cutoff value used to determine vitamin D deficiency is not yet validated for our ethnic group; we also don't know the optimal vitamin D level for our population. Before coming to any firm conclusion regarding nationwide vitamin D deficiency, we must know the Optimal range of serum Vitamin D for our people of Bangladesh. As sunlight is the primary source of vitamin D and adequate sun exposure alone is sufficient to produce enough vitamin D to maintain the physiological demand without producing toxicity. According to Holick's rule, exposure to sunlight at the face and both arms for 25 min, 3 times a week should maintain adequate vitamin D status. In Indonesia, it was found that after exposure to sunlight at this specific time and duration for 6 weeks, the mean 25(OH)D levels of participants increased from 59 nmol/L at the baseline to 84 nmol/L.In India, exposure to sunlight for 30 minutes, between 11 am and 2 pm, three times a week, is sufficient to maintain adequate serum vitamin D concentration. Therefore it could be assumed that healthy subjects without any risk factors for vitamin D deficiency and having adequate sun exposure should maintain an Optimal serum vitamin D concentration. Here Optimal means a range where there will be no features of insufficiency or toxicity. In this cross-sectional study, we want to find out the serum vitamin D level of such a population, representing the Optimal level of vitamin D for Bangladeshi people.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Bangladesh; Optimal Level; Coastal fishermen; Parathyroid Hormone; Reference interval

Outcome Measures

Primary Outcomes (1)

• Serum vitamin D levels

  Serum vitamin D levels of healthy fishermen, healthy volunteers and healthy healthcare workers will be measured in the chemiluminescent microparticle immunoassay method.

  Day 1

Secondary Outcomes (1)

• Serum parathyroid hormone levels

  Day 1

Study Arms (2)

Adequately sun-exposed healthy population

Healthy coastal fishermen of Cox's Bazar district of Bangladesh

Diagnostic Test: Serum vitamin D assay

Inadequately sun-exposed healthy population

Healthcare workers of the selected hospitals of Dhaka, Bangladesh

Diagnostic Test: Serum vitamin D assay

Interventions

Serum vitamin D assay DIAGNOSTIC_TEST

Trained phlebotomists will collect 10 cc of a Blood sample. Specimen will be preserved at -40ºc for batch analysis. S Vitamin D, S iPTH, S Calcium, S Alkaline Phosphatase, S PO4, S Mg, S Albumin and S Creatinine will be done in BIRDEM laboratory. Vitamin D will be assayed by The ARCHITECT 25-OH Vitamin D assay system: Vitamin D will be assayed by The ARCHITECT 25-OH Vitamin D assay system: The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent micro-particle immunoassay (CMIA). This technology is used for the quantitative analysis of 25(OH) D and aid in the assessment of vitamin D sufficiency.

Also known as: Serum iPTH assay

Adequately sun-exposed healthy population; Inadequately sun-exposed healthy population

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adequately sun-exposed healthy population: Healthy fishermen with at least 30 minutes of sun exposure between 11 am and 2 pm, three times a week for the preceding 6 months. All male aged 18 to 65 years Inadequately sun-exposed healthy population: Urban, office-based workers or homemakers, both male and female, who will come for a routine health check-up in the BIRDEM outpatient department, and health care workers of selected hospitals of Dhaka. Both male and female aged 18 to 65 years.

You may qualify if:

• Healthy fishermen
• Healthy health care workers
• Who will be willing to participate in the study

You may not qualify if:

• Those who will refuse to participate in the interview
• Physically and psychologically handicapped
• Subjects with known chronic illnesses like liver, kidney or gastrointestinal disease, metabolic bone disease, malignancy, pregnancy and lactation, history of immobility for more than 1 week, on vitamin D or calcium supplementation, on anti-epileptic drugs
• Primary hyperparathyroidism
• Subject having lactose intolerance

Sponsors & Collaborators

• Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders: lead
• Bangladesh Medical Research Council (BMRC): collaborator

Study Sites (2)

Cox's Bazar

Cox’s Bāzār, 4700, Bangladesh

Location

BIRDEM General Hospital

Dhaka, 1000, Bangladesh

Location

Related Publications (31)

• Wacker M, Holick MF. Sunlight and Vitamin D: A global perspective for health. Dermatoendocrinol. 2013 Jan 1;5(1):51-108. doi: 10.4161/derm.24494.

  PMID: 24494042 BACKGROUND

• Nimitphong H, Holick MF. Vitamin D status and sun exposure in southeast Asia. Dermatoendocrinol. 2013 Jan 1;5(1):34-7. doi: 10.4161/derm.24054.

  PMID: 24494040 BACKGROUND

• Harinarayan CV, Holick MF, Prasad UV, Vani PS, Himabindu G. Vitamin D status and sun exposure in India. Dermatoendocrinol. 2013 Jan 1;5(1):130-41. doi: 10.4161/derm.23873.

  PMID: 24494046 BACKGROUND

• Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1678S-88S. doi: 10.1093/ajcn/80.6.1678S.

  PMID: 15585788 BACKGROUND

• Walentowicz-Sadlecka M, Sadlecki P, Walentowicz P, Grabiec M. [The role of vitamin D in the carcinogenesis of breast and ovarian cancer]. Ginekol Pol. 2013 Apr;84(4):305-8. doi: 10.17772/gp/1581. Polish.

  PMID: 23700865 BACKGROUND

• Wacker M, Holick MF. Vitamin D - effects on skeletal and extraskeletal health and the need for supplementation. Nutrients. 2013 Jan 10;5(1):111-48. doi: 10.3390/nu5010111.

  PMID: 23306192 BACKGROUND

• Wimalawansa SJ. Vitamin D in the new millennium. Curr Osteoporos Rep. 2012 Mar;10(1):4-15. doi: 10.1007/s11914-011-0094-8.

  PMID: 22249582 BACKGROUND

• Holick MF. Vitamin D: extraskeletal health. Rheum Dis Clin North Am. 2012 Feb;38(1):141-60. doi: 10.1016/j.rdc.2012.03.013. Epub 2012 Apr 12.

  PMID: 22525849 BACKGROUND

• Bischoff-Ferrari H. Vitamin D - from essentiality to functionality. Int J Vitam Nutr Res. 2012 Oct;82(5):321-6. doi: 10.1024/0300-9831/a000126.

  PMID: 23798050 BACKGROUND

• Moreno LA, Valtuena J, Perez-Lopez F, Gonzalez-Gross M. Health effects related to low vitamin D concentrations: beyond bone metabolism. Ann Nutr Metab. 2011;59(1):22-7. doi: 10.1159/000332070. Epub 2011 Nov 25.

  PMID: 22123633 BACKGROUND

• Need AG, Horowitz M, Morris HA, Nordin BC. Vitamin D status: effects on parathyroid hormone and 1, 25-dihydroxyvitamin D in postmenopausal women. Am J Clin Nutr. 2000 Jun;71(6):1577-81. doi: 10.1093/ajcn/71.6.1577.

  PMID: 10837301 BACKGROUND

• von Muhlen DG, Greendale GA, Garland CF, Wan L, Barrett-Connor E. Vitamin D, parathyroid hormone levels and bone mineral density in community-dwelling older women: the Rancho Bernardo Study. Osteoporos Int. 2005 Dec;16(12):1721-6. doi: 10.1007/s00198-005-1910-8. Epub 2005 Jun 1.

  PMID: 15928802 BACKGROUND

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• Thomas MK, Lloyd-Jones DM, Thadhani RI, Shaw AC, Deraska DJ, Kitch BT, Vamvakas EC, Dick IM, Prince RL, Finkelstein JS. Hypovitaminosis D in medical inpatients. N Engl J Med. 1998 Mar 19;338(12):777-83. doi: 10.1056/NEJM199803193381201.

  PMID: 9504937 BACKGROUND

• Chapuy MC, Preziosi P, Maamer M, Arnaud S, Galan P, Hercberg S, Meunier PJ. Prevalence of vitamin D insufficiency in an adult normal population. Osteoporos Int. 1997;7(5):439-43. doi: 10.1007/s001980050030.

  PMID: 9425501 BACKGROUND

• Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.

  PMID: 18400738 BACKGROUND

• Vierucci F, Del Pistoia M, Fanos M, Erba P, Saggese G. Prevalence of hypovitaminosis D and predictors of vitamin D status in Italian healthy adolescents. Ital J Pediatr. 2014 Jun 5;40:54. doi: 10.1186/1824-7288-40-54.

  PMID: 24902694 BACKGROUND

• G R, Gupta A. Vitamin D deficiency in India: prevalence, causalities and interventions. Nutrients. 2014 Feb 21;6(2):729-75. doi: 10.3390/nu6020729.

  PMID: 24566435 BACKGROUND

• Beloyartseva M, Mithal A, Kaur P, Kalra S, Baruah MP, Mukhopadhyay S, Bantwal G, Bandgar TR. Widespread vitamin D deficiency among Indian health care professionals. Arch Osteoporos. 2012;7:187-92. doi: 10.1007/s11657-012-0096-x. Epub 2012 Sep 28.

  PMID: 23225296 BACKGROUND

• Zargar AH, Ahmad S, Masoodi SR, Wani AI, Bashir MI, Laway BA, Shah ZA. Vitamin D status in apparently healthy adults in Kashmir Valley of Indian subcontinent. Postgrad Med J. 2007 Nov;83(985):713-6. doi: 10.1136/pgmj.2007.059113.

  PMID: 17989271 BACKGROUND

• Isaia G, Giorgino R, Rini GB, Bevilacqua M, Maugeri D, Adami S. Prevalence of hypovitaminosis D in elderly women in Italy: clinical consequences and risk factors. Osteoporos Int. 2003 Jul;14(7):577-82. doi: 10.1007/s00198-003-1390-7. Epub 2003 Jul 11.

  PMID: 12856111 BACKGROUND

• Sedrani SH. Low 25-hydroxyvitamin D and normal serum calcium concentrations in Saudi Arabia: Riyadh region. Ann Nutr Metab. 1984;28(3):181-5. doi: 10.1159/000176801.

  PMID: 6610383 BACKGROUND

• Goswami R, Gupta N, Goswami D, Marwaha RK, Tandon N, Kochupillai N. Prevalence and significance of low 25-hydroxyvitamin D concentrations in healthy subjects in Delhi. Am J Clin Nutr. 2000 Aug;72(2):472-5. doi: 10.1093/ajcn/72.2.472.

  PMID: 10919943 BACKGROUND

• Hwang JS, Tsai KS, Cheng YM, Chen WJ, Tu ST, Lu KH, Hou SM, Yang SH, Cheng H, Lai HJ, Lei S, Chen JF. Vitamin D status in non-supplemented postmenopausal Taiwanese women with osteoporosis and fragility fracture. BMC Musculoskelet Disord. 2014 Jul 28;15:257. doi: 10.1186/1471-2474-15-257.

  PMID: 25069806 BACKGROUND

• Baidya A, Chowdhury S, Mukhopadhyay S, Ghosh S. Profile of vitamin D in a cohort of physicians and diabetologists in Kolkata. Indian J Endocrinol Metab. 2012 Dec;16(Suppl 2):S416-7. doi: 10.4103/2230-8210.104113.

  PMID: 23565448 BACKGROUND

• Micka A. Vitamin D Status among Bangladeshi Women of Reproductive Age [Masters Theses ]. ScholarWorks@UMass Amherst: University of Massachusetts Amherst; 2009

  BACKGROUND

• Islam MZ, Lamberg-Allardt C, Karkkainen M, Outila T, Salamatullah Q, Shamim AA. Vitamin D deficiency: a concern in premenopausal Bangladeshi women of two socio-economic groups in rural and urban region. Eur J Clin Nutr. 2002 Jan;56(1):51-6. doi: 10.1038/sj.ejcn.1601284.

  PMID: 11840180 BACKGROUND

• Islam MZ, Akhtaruzzaman M, Lamberg-Allardt C. Hypovitaminosis D is common in both veiled and nonveiled Bangladeshi women. Asia Pac J Clin Nutr. 2006;15(1):81-7.

  PMID: 16500882 BACKGROUND

• Islam MZ, Shamim AA, Kemi V, Nevanlinna A, Akhtaruzzaman M, Laaksonen M, Jehan AH, Jahan K, Khan HU, Lamberg-Allardt C. Vitamin D deficiency and low bone status in adult female garment factory workers in Bangladesh. Br J Nutr. 2008 Jun;99(6):1322-9. doi: 10.1017/S0007114508894445.

  PMID: 18430266 BACKGROUND

• Roth DE, Shah MR, Black RE, Baqui AH. Vitamin D status of infants in northeastern rural Bangladesh: preliminary observations and a review of potential determinants. J Health Popul Nutr. 2010 Oct;28(5):458-69. doi: 10.3329/jhpn.v28i5.6154.

  PMID: 20941897 BACKGROUND

• Ketteler M, Block GA, Evenepoel P, Fukagawa M, Herzog CA, McCann L, Moe SM, Shroff R, Tonelli MA, Toussaint ND, Vervloet MG, Leonard MB. Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder: Synopsis of the Kidney Disease: Improving Global Outcomes 2017 Clinical Practice Guideline Update. Ann Intern Med. 2018 Mar 20;168(6):422-430. doi: 10.7326/M17-2640. Epub 2018 Feb 20.

  PMID: 29459980 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Wasim Md Mohosin Ul Haque, FCPS

  Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: August 2, 2021
• Study Start: January 1, 2017
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)