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Vitamin D DeficiencyNCT04986319

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

An observational study of Vitamin D Deficiency, run by Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders at 2 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency
What is being tested?
Serum vitamin D assay
How many people
556 participants
Where
2 sitesBangladesh
Study dates
Jan 2017to 15 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Bangladesh2 sites
  • Cox's Bazar

    Cox’s Bāzār, 4700

  • BIRDEM General Hospital

    Dhaka, 1000

Other trials in Bangladesh

About this study

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

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.

Read the detailed description

Vitamin D is the sunshine vitamin produced on this earth for more than 500 million years. This is produced in humans by sunlight. Sunlight is the main 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 on 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. Lack of adequate sun exposure as a consequence of urbanization prone human races to a threat of hypovitaminosis D. Vitamin D (25-hydroxyvitamin D) insufficiency and its impending consequence on health is now the subject of important concern and controversy. The optimal value of vitamin D substantially differs among populations depending upon environmental, cultural and racial factors. However, the definition of vitamin D insufficiency is still not out of controversy, mostly cutoffs of <50 nmol/L of serum 25-hydroxyvitamin D (25(OH)D) level is considered as "vitamin D deficiency" state, 50 to 74.9 nmol/L denotes "insufficiency" and ≥75 nmol/L considered as "sufficiency".

With the falling of serum25 (OH)D beyond a certain point, absorption of calcium from the gut decreases, which leads to a surge of parathyroid hormone (PTH) secretion, which in turn stimulates the conversion of 25(OH)D to 1,25(OH)2D to keep calcium at a normal limit. Thus, a higher value of PTH could be considered as a surrogate marker of vitamin D insufficiency. Serum 25(OH) D below the level of 75-100 nmol/L has an inverse correlation with PTH concentration; beyond this point, serum intact PTH concentration remains in a plateau state.

Based on these definitions, the whole world faces a pandemic of vitamin D deficiency/insufficiency. According to recent studies, the prevalence of vitamin D deficiency has been found between 30% and 100% in different communities. This picture is similar in the USA, Europe, South East Asia and the Middle East. In India, the prevalence of Vitamin D deficiency is around 70%-100% in the general population. Baidya et al. (2012) studied 40 healthy Indian physicians in Calcutta. Around 97.5% of subjects had low vitamin D. Mean age and meant 25(OH)D levels of that cohort were 52.22 ± 10 years and 13.02 ± 4.77 ng/ml (32.50±11.91 nmol/L). Vitamin D deficiency was found in 92.5% of participants. Though available data in Bangladesh are confined to female subjects only, the scenario is not different. More than ninety-nine percent of Bangladesh female garment workers were vitamin D insufficient in a study.

This picture is alarming because, in addition to its deleterious effect on the musculoskeletal system, vitamin D deficiency is also linked with many other medical issues like cardiovascular disease, malignancy, neuromodulation, diabetes, and metabolic syndrome several autoimmune diseases (such as multiple sclerosis, Crohn's disease and ulcerative colitis) and certain infectious diseases, such as tuberculosis. Vitamin D supplementation is also a key component in the hierarchy of management of Chronic Kidney Disease-Mineral and Bone Disorder.

However, the caveat of all of those studies done in Bangladesh and neighbouring countries like India and Pakistan is that the cutoff value used to determine vitamin D deficiency or insufficiency has not yet been validated for the corresponding population. Before reaching a firm conclusion about epidemics of vitamin D deficiency and planning for supplementation programs, the cutoff value of vitamin D deficiency/insufficiency of the Bangladeshi population must be validated. The optimal level of vitamin D for the Bangladeshi population should also find out.

Rationale: Maintenance of adequate vitamin D levels undoubtedly is an important human health issue. It helps prevent many chronic diseases, which in fact are in addition to its principal role in maintaining appropriate blood calcium levels. To get the optimum beneficial effects of vitamin D, including prevention of many potential adverse health effects caused by deficient vitamin D, circulating 25(OH)D levels should be within the normal range. Vitamin D varies depending on various factors like exposure to the sun, age, race, body mass index, lack of exercise etc. The cutoff value for deficiency and insufficiency also varies between studies. Several studies using prescribed cutoff values of vitamin D deficiency reveal an epidemic of vitamin D deficiency in our country, despite abounded sunlight due to the proximity of the equator. However, no study was done previously in Bangladesh to determine the Optimal value of vitamin D representative of this population. The deficiency and insufficiency levels are ignorant and when to intervene is also not known. That is why it is important to conduct this exploratory study. It will help to assume the optimal reference range of serum vitamin D for the Bangladeshi population. That will give a clearer picture of the actual burden of vitamin D deficiency in Bangladesh and guide them to treat them and take necessary preventive measures at the national level.

Being tested
Serum vitamin D assay
Keywords
Vitamin D, Bangladesh, Optimal Level, Coastal fishermen, Parathyroid Hormone, Reference interval
Medical subject headings
Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum vitamin D assayDiagnostic test

    Also called Serum iPTH 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.

Study groups in NCT04986319
Study groupRoleWhat they receive
Adequately sun-exposed healthy populationHealthy coastal fishermen of Cox's Bazar district of Bangladesh
Receives: Diagnostic Test: Serum vitamin D assay
Inadequately sun-exposed healthy populationHealthcare workers of the selected hospitals of Dhaka, Bangladesh
Receives: Diagnostic Test: Serum vitamin D assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Secondary outcomes (1)
  1. Serum parathyroid hormone levels

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study startJan 2017
  3. Primary completion15 Aug 2021
  4. Study completion15 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986319
Sponsor's protocol ID
BADAS-ERC/EC/21/00310
Status last verified
Aug 2021
First submitted
26 May 2021
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24494042
  • 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.

    PubMed 24494040
  • 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.

    PubMed 24494046
  • 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.

    PubMed 15585788
  • 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.

    PubMed 23700865
  • 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.

    PubMed 23306192
  • Wimalawansa SJ. Vitamin D in the new millennium. Curr Osteoporos Rep. 2012 Mar;10(1):4-15. doi: 10.1007/s11914-011-0094-8.

    PubMed 22249582
  • 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.

    PubMed 22525849
  • 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.

    PubMed 23798050
  • 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.

    PubMed 22123633
  • 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.

    PubMed 10837301
  • 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.

    PubMed 15928802
  • Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

    PubMed 17634462
  • 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.

    PubMed 9504937
  • 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.

    PubMed 9425501

Questions about this trial

What is this clinical trial studying?

An observational study of Vitamin D Deficiency, run by Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders at 2 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum vitamin D levels (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986319, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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