CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 556 enrolled
Drug / intervention
Serum vitamin D assayother
Likely dose
Not stated in record
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Search/NCT04986319
NCT04986319N/ACompleted

The Level of Serum Vitamin D And Parathyroid Hormone Among Different Bangladeshi Population Groups

In Brief

An observational study evaluating Serum vitamin D assay for Vitamin D Deficiency. Completed, enrolled 556 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2, 2021
Enrollment StartJan 1, 2017
Primary CompletionAug 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 4.9 years ago

Interventions

Serum vitamin D assayother

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.