Healthy Volunteers
Conditions
Interventions
Healthy Thai adults, male or female, aged 18 to 60 years. Participants must have a documented normal serum 25 hydroxyvitamin D level between 30 and 100 ng/mL within 6 months prior to enrollment.
Other
Healthy Thai adults
Sponsors
Thai Red Cross Society Research Grant
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 60 years. 2. Documented serum 25(OH)D level more than 30 ng/mL within 6 months prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding, 2. Acute illness within 2 weeks prior to blood collection including fever vomiting or diarrhea, 3. Presence of chronic or acute diseases that may affect calcium phosphate parathyroid hormone metabolism including Chronic kidney disease eGFR less than 60 mL/min/1.73 m2 calculated by the CKD EPI equation, Chronic liver disease Cirrhosis Child Pugh class B or C, Parathyroid disorders including primary hyperparathyroidism hypoparathyroidism or history of parathyroidectomy and Familial Hypocalciuric Hypercalcemia FHH, Metabolic bone diseases including treated osteoporosis osteomalacia and Pagets disease, History of bone fracture within the past 6 months, Active malignancy within the past 1 year, Chronic inflammatory bowel disease malabsorption syndromes or history of bariatric surgery, 4. Use of medications or supplements that affect PTH or calcium phosphate balance for at least 3 months such as Lithium thiazide or loop diuretics, Calcimimetics cinacalcet etelcalcetide, Bisphosphonates denosumab teriparatide, SGLT2 inhibitor, Anticonvulsants phenytoin carbamazepine valproate, Biotin more than 5 mg per day within 48 hours, 5. History of smoking more than 10 cigarettes per day within the past 6 months or alcohol consumption exceeding 3 standard drinks per day within the past 1 week, 6. Serum 25OHD level on the day of blood sampling less than 30 ng/mL or more than 100 ng/mL, 7. Renal function eGFR less than 60 mL/min/1.73 m2, 8. Albumin corrected calcium phosphate or magnesium levels outside the laboratory normal reference intervals, 9. Incomplete 24 hour urine collection assessed by 24 hour urinary creatinine excretion or abnormally low urine volume, 10. Suspected Familial Hypocalciuric Hypercalcemia FHH where Calcium Creatinine Clearance Ratio CCCR is lower than 0.01
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intact parathyroid hormone level and whole parathyroid hormone level At a single time point on the day of blood collection Laboratory measurement using automated immunoassay analyzers (Abbott Alinity i, Roche cobas e, and DiaSorin LIAISON XL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of 25-hydroxyvitamin D, creatinine, calcium, phosphate, magnesium, and albumin, along with age, sex, and body mass index At a single time point on the day of blood collection Laboratory measurement using automated chemistry analyzers for biochemical parameters, and standard clinical measurement for anthropometric data | — |
Countries
Thailand
Contacts
Public ContactPanudda Srichomkwun
King Chulalongkorn Memorial Hospital, The Thai Red Cross Society
Outcome results
None listed