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A Single High-dose Oral Supplement of Vitamin D in Young Chinese

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02158143
Enrollment
28
Registered
2014-06-06
Start date
2013-10-31
Completion date
Unknown
Last updated
2014-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Brief summary

evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.

Interventions

DIETARY_SUPPLEMENTvitamin D3

Sponsors

Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years; * haven't taken vitamin D supplement for the past 6 months; * with a normal BMI (18-25 kg/m2); * with baseline serum 25(OH)D \< 30 ng/ml; * be willing to follow the instruction and complete the study.

Exclusion criteria

* clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness; * self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment; * Severe anemia (hemoglobin concentration \< 70 g/L); * Serum 25(OH)D ≥ 30 ng/mL at enrollment; * participating in other research studies within the 3 months before enrollment; * history of drug dependence or drug abuse; * History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day); * clinical abnormal of blood biochemistry, hematology or urine laboratory values; * current pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Effect of vitamin D3 supplementation on serum PTHwithin 140 day after supplementation
Effect of vitamin D3 supplementation on serum creatininewithin 140 day of supplementation
Effect of vitamin D3 supplementation on urinary calcium / creatininewithin 140 day after supplementation
Effect of vitamin D3 supplementation on serum 25(OH)D changeswithin 140 day after supplementation
Effect of vitamin D3 supplementation on serum calciumwithin 140 day after supplementation

Secondary

MeasureTime frame
Effect of vitamin D3 supplementation on serum lipidswithin 140 day after supplementation
Effect of vitamin D3 supplementation on fasting blood glucosewithin 140 day after supplementation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026