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.
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
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.
- Conditions
- Vitamin D Deficiency
- 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 group | Role | What they receive |
|---|---|---|
| Adequately sun-exposed healthy population | Healthy coastal fishermen of Cox's Bazar district of Bangladesh Receives: Diagnostic Test: Serum vitamin D assay | |
| Inadequately sun-exposed healthy population | Healthcare 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.
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)
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.
- First posted2 Aug 2021
- Study startJan 2017
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Medical Research Council (BMRC)
- Responsible party
- Principal investigator, Wasim Md Mohosin Ul Haque, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Investigators
- Wasim Md Mohosin Ul Haque, FCPS, Principal investigator, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
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 24494042Nimitphong 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 24494040Harinarayan 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 24494046Holick 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 15585788Walentowicz-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 23700865Wacker 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 23306192Wimalawansa SJ. Vitamin D in the new millennium. Curr Osteoporos Rep. 2012 Mar;10(1):4-15. doi: 10.1007/s11914-011-0094-8.
PubMed 22249582Holick 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 22525849Bischoff-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 23798050Moreno 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 22123633Need 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 10837301von 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 15928802Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Thomas 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 9504937Chapuy 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Level of Serum Vitamin D And Parathyroid Hormone Among Different Bangladeshi Population Groups
- ClinicalTrials.gov ID
- NCT04986319
- Acronym / sponsor ID
- BADAS-ERC/EC/21/00310
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Bangladesh, Optimal Level, Coastal fishermen, Parathyroid Hormone, Reference interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic DisordersUniversity, hospital or other
- Collaborators
- Bangladesh Medical Research Council (BMRC)
- Study start
- Jan 2017 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adequately sun-exposed healthy population | – | Diagnostic Test: Serum vitamin D assayHealthy coastal fishermen of Cox's Bazar district of Bangladesh |
| Inadequately sun-exposed healthy population | – | Diagnostic Test: Serum vitamin D assayHealthcare workers of the selected hospitals of Dhaka, Bangladesh |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Healthy fishermen
- Healthy health care workers
- Who will be willing to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum vitamin D assayAlso: Serum iPTH assayTrained 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. | Diagnostic test | Adequately sun-exposed healthy population, Inadequately sun-exposed healthy population |
Primary outcome
Serum vitamin D levels
Time frame: Day 1
Serum vitamin D levels of healthy fishermen, healthy volunteers and healthy healthcare workers will be measured in the chemiluminescent microparticle immunoassay method.
1 secondary outcome
Serum parathyroid hormone levels
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 24494042Wacker 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.
- Background: PubMed 24494040Nimitphong 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.
- Background: PubMed 24494046Harinarayan 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.
- Background: PubMed 15585788Holick 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.
- Background: PubMed 23700865Walentowicz-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.
- Background: PubMed 23306192Wacker 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.
- Background: PubMed 22249582Wimalawansa SJ. Vitamin D in the new millennium. Curr Osteoporos Rep. 2012 Mar;10(1):4-15. doi: 10.1007/s11914-011-0094-8.
- Background: PubMed 22525849Holick 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.
- Background: PubMed 23798050Bischoff-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.
- Background: PubMed 22123633Moreno 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.
- Background: PubMed 10837301Need 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.
- Background: PubMed 15928802von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasim Md Mohosin Ul Haque, FCPS principal investigator
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
2 sites in 1 country: see every site and its status.
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.