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Vitamin D DeficiencyPhase 1NCT01998763

Vitamin D Intervention Trial in Healthy Chinese, Phase II

A Phase 1 study testing Vitamin D3 in people with Vitamin D Deficiency, run by Chinese Academy of Sciences at 1 site in China.

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

This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to placebo or 2000 IU/d vitamin D3 arm, after taking… Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
448 participants
Where
1 siteChina
Study dates
Nov 2013to Dec 2015
Phase
Phase 1
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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 20-45 years. with vitamin D deficiency (12.5 ≤ 25(OH)D < 50 nmol/l)

Who cannot join

  • BMI < 18.5 kg/m2, or BMI ≥ 25 kg/m2
  • Total intake of calcium from diet or supplements >1200mg/d, or fasting serum calcium level ≥2.75 mmol/l
  • Participating in other clinical studies within previous 3 months
  • Taking vitamin D supplements within previous 3 months
  • Using medications that may affect vitamin D metabolism in previous 3 months;
  • Concomitant with clinical conditions, like liver dysfunction (serum alanine transaminase (ALT) ≥40 U/L; and/or aspartate transaminase (AST) ≥40 U/L; Glutamyl transpeptidase (GGT)≥50 U/L; serum creatinine < 50 or > 120 µmol/L; urea nitrogen (UN) < 7 or > 18 mg/dl, and/or urine acid <90 or >420 µmol/L; which may affect vitamin D metabolism;
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  • History of drug or alcohol abuse (>40 g/d)
  • Women during pregnancy or lactation
  • Individuals with mental disorders or current use of antidepressants, the conditions which may affect him or her understanding and unwillingness to the intervention;
  • Having clinically diagnosed AIDS, hepatitis A, hepatitis B, tuberculosis and other infectious diseases.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

    Shanghai

Other trials in China

About this study

Official title: Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study

This is a double-blind, randomized, placebo-controlled trial. Based on inclusion and exclusion criteria, 400 eligible volunteers, who were 20-45 years, with 25-hydroxyvitamin D between 12.5-50 nmol/L and BMI between 18.5-28 kg/m2, were enrolled and randomly assigned to placebo or 2000 IU/d vitamin D3 arm, after taking placebo for one week. The study protocol was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University, Shanghai and all participants provided written informed consents.In this 2-arm RCT we aimed to systematically investigate the effect of:

  1. vitamin D3 supplement on serum 25(OH)D levels and the modifying factors;
  2. genetic and non-genetic variants on vitamin D bioavailability;
  3. vitamin D3 supplementation on metabolic profiles and circulating bone-turnover markers
Read the detailed description

At present time, the Recommended Dietary Allowance (RDA) and the tolerable upper intake level (UL) for vitamin D are 200 IU/day and 800 IU/day for Chinese aged 11-50 years, respectively. On the other hand, the RDA and UL for vitamin D for the same age group in USA are 600IU/day and 4000IU/day, respectively. Indeed, recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D] concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount from other sources, is needed, which is twice as much as the RDA recommended by Chinese Nutrition Society. Except for those individuals with hypersensitive conditions, daily intake less than 10,000 IU of vitamin D have not shown overt adverse effects based upon the studies conducted in Western populations.

Since vitamin D metabolic rate and its relationship with health outcomes may vary across different ethnical groups and most available data so far were from Caucasians populations, it remains to be elucidated whether the findings from Western population could apply directly to Asian peoples like Chinese. Recently, our group has conducted the first relatively large-scale study in Asian to evaluate the association between 25(OH)D and risk of metabolic syndrome. It was found that the geometric mean of plasma 25(OH)D in these Chinese adults aged 50-70 years from Beijing and Shanghai (n=3210) was 40.36 nmol/l and percentage of vitamin D deficiency [25(OH)D <50 nmol/l] and insufficiency (50 ≤ 25(OH)D < 75 nmol/l) were 69.2% and 24.4%, respectively. Comparing the lowest with the highest 25(OH)D quintile (≤28.7 nmol/l vs. ≥57.7 nmol/l), the odds ratio for metabolic syndrome (MetS) was 1.52 (95% CI 1.17-1.98, P for trend = 0.0002), after multiple adjustment. Significant inverse associations also existed between 25(OH)D and most of MetS components, plus HbA1c. Moreover, low plasma 25(OH)D level was found to be associated with increased insulin resistance index (homeostasis model assessment of insulin resistance, HOMA-IR) in those overweight and obese individuals (BMI ≥24 kg/m2),. (Lu et al., Diabetes Care, 2009). According to the data from 2002 China National Nutrition Survey, high prevalence of vitamin D deficiency also exited in Chinese children aged 1-3 years and approximate 82% of them had circulating 25(OH)D ≤ 50nmol/L. In consistent with our finding, a report from a population-based Korea study showed that the association between 25(OH)D and insulin resistance was modified by BMI status (Choi et al.,The Journal of Nutrition,2011).

In our recent genetic study, it was found that genetic variants at GC and NADSYN1/DHCR7 were significantly associated with circulating 25(OH)D levels while marginal association between CYP2R1-rs2060793 and 25(OH)D levels was observed only in the Shanghai subpopulation (Lu et al., Human Genetics 2011). In addition, we developed a genetic risk score (GRS) to evaluate the combined effect of three SNPs (rs4588, rs1790349 and rs2060793) from GC, NADSYN1/DHCR7 and CYP2R. Notably, the average plasma 25(OH)D concentration in individuals with 5-6 risk allele was 11.4 nmol/l lower than those without risk allele. Indeed, previous studies suggested that intake of 100 IU vitamin D could only raise circulating 25(OH)D by 2.5 nmol/l, implicating that 450 IU of extra vitamin D is required for these high risk individuals. The possible interpretations for such a high prevalence of poor vitamin D nutrition among Chinese may be due to the factors: (1) unlike United States and other Western countries, few, if any, vitamin D enriched or fortified foods are available in China; (2) Chinese, particularly women, like to have pale skin color, who therefore frequently utilize sunscreen and umbrella to prevent sun exposure. (3) approximate 318 million people are living in Heilongjiang, Shaanxi, Jilin, Shanxi, Liaoning, Qinghai, Gansu, Inner Mongolia, Xinjiang, and Hebei provinces, the areas with latitude N37°, which was previously showed to prevent skin synthesizing sufficient vitamin D during winter time. Collectively, all of these factors suggest that large proportions of Chinese may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be too low to provide adequate vitamin D for people's health. In order to fill up this gap, therefore, it is essential to study the bioavailability following vitamin D intervention and also identify the effects of genetic variants and other factors on vitamin D metabolism and associated health outcomes. Ultimately, the current study will provide important evidence for establishing optimal vitamin D requirement for Chinese people.

Being tested
Placebo, Vitamin D3
Keywords
Vitamin D3 supplementation, metabolite profile, SNPs, bone-turnover marker
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.

  • PlaceboDietary supplement

    placebo capsules have similar appearance and smell as 400 IU vitamin D3 capsules,

  • Vitamin D3Dietary supplement

    Vitamin D3 2000 IU per day

Study groups in NCT01998763
Study groupRoleWhat they receive
PlaceboPlacebo comparator5 placebo pills per day, 20 weeks
Receives: Dietary Supplement: Placebo
2000 IU/d Vitamin D3Experimental5 vitamin D3 pills per day, 20 weeks
Receives: Dietary Supplement: Vitamin D3

What is being measured

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

  1. 25-hydroxyvitamin D

    Serum 25(OH)D (D2+D3) concentration was measured by a liquid chromatography-mass spectrometry (LC-MS) method

    Measured: 0,10,20 week

Secondary outcomes (3)
  1. calcium

    Serum calcium was measured by an automatic biochemical analyzer

    Measured: 0,10,20 week

  2. parathyroid hormone

    Serum iPTH was measured by ADVIA Centaur XP Immunoassay System (Siemens, Germany)

    Measured: 0,10,20 week

  3. Vitamin D binding protein

    Serum VDBP was measured by an ELISA kit

    Measured: 0,10,20 week

Timeline

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

  1. First posted2 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2014
  4. Study completionDec 2015

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01998763
Sponsor's protocol ID
KSCX2-EW-R-10-VDII
Other IDs
KSCX2-EW-R-10
Status last verified
Jan 2016
First submitted
25 Nov 2013
Last updated
22 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Yao P, Sun L, Xiong Q, Xu X, Li H, Lin X. Cholecalciferol Supplementation Promotes Bone Turnover in Chinese Adults with Vitamin D Deficiency. J Nutr. 2018 May 1;148(5):746-751. doi: 10.1093/jn/nxy032.

    PubMed 29897564
  • Yao P, Sun L, Lu L, Ding H, Chen X, Tang L, Xu X, Liu G, Hu Y, Ma Y, Wang F, Jin Q, Zheng H, Yin H, Zeng R, Chen Y, Hu FB, Li H, Lin X. Effects of Genetic and Nongenetic Factors on Total and Bioavailable 25(OH)D Responses to Vitamin D Supplementation. J Clin Endocrinol Metab. 2017 Jan 1;102(1):100-110. doi: 10.1210/jc.2016-2930.

    PubMed 27768857

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin D3 in people with Vitamin D Deficiency, run by Chinese Academy of Sciences at 1 site in China.

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 1 inclusion and 10 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

25-hydroxyvitamin D (time frame: 0,10,20 week). 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 NCT01998763, which also lists 2 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 22 Jan 2016.

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