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

NCT04986319 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2021-08-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Serum vitamin D assay

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.

Sponsors & Collaborators

  • Bangladesh Medical Research Council (BMRC)

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Wasim Md Mohosin Ul Haque, FCPS · Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-08-15
Completion
2021-08-15

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04986319 on ClinicalTrials.gov