Controlled, Randomized, Four-arm Comparative, Open Label, Multi-centric Clinical Trial to Compare the Efficacy and Safety Parameters of the Once-a-week or Once-a-month Administered 7000 IU, or 30000 IU Vitamin D (Cholecalciferol) to a 1000 IU Dosage Applied Daily in Vitamin D Deficient Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Circa-annual variations in 25-hydroxyvitamin D \[25(OH)D\] levels have been well established, and there also seems to be an effect of season on bone turnover and bone mass. been shown that bone turnover follows a circa-annual rhythm. On the basis of human clinical results, it was suggested that adipose tissue functions as a vitamin D buffering system that to a certain extent prevents uncontrolled synthesis of 25(OH)D in the liver. Directly related to this issue is the question of how much vitamin D is needed to ensure target serum 25-hydroxyvitamin D \[25(OH)D\] concentrations. According to the recommended dietary allowances, persons should achieve "levels of intake of essential nutrients considered to be adequate to meet the known nutritional needs of practically all healthy persons" Moreover it is important to note that the significant percentage of the population is temporarily of continuously deficient in vitamin D. In the similar condition of vitamin D deficiency, the aetiology is very different since only as almost exclusively as a consequence of a primary disease in children it is manifested: hypovitaminosis D is highly prevalent among children on renal substitution therapy, regardless of the type of therapy used and the stage of renal failure.

The rationale providing high dose strengths of vitamin D based on an assumption of better compliance especially in adult with senior age patients; also a potential for faster resolution of vitamin D deficiency, since utilization of cholecalciferol is higher when patients had low levels of 25(OH)D, and vice versa, there is a plateau phase when close to normal range (Vieth 2001).

According to clinical data, a doses equivalent of daily 1000 IU, (7000 IU per week, or 30000 IU per month) is considered as a minimal effective dose to treat vitamin D deficiency. The treatment of vitamin D with a duration of 30 days may result and increase of 6-12.5 nmol/L. With the deficiency criteria considered as \<20 ng/ml, the vitamin supplementation is indicative, the treatment dosages should be adjusted to the increase planned to achieve the mid-normal range.

As the base of calculations, the doses of 40 IU results in an increase of 0.4 ng/ml in a period of 60 days. Accordingly 1000 IU in a period of 2-5 month resulted in an increase of approx 10 ng/ml. The risk of overdose in relatively low, since the absorption and the metabolic path is well controlled: automatic mechanisms downregulation at normal ranges.

In this study the there are three groups in the similar daily dose equivalent of 1000 IU/day. The absorption of daily , weekly and monthly dosing should have a buffered effect due to the body adipose tissues, balancing the daily 1,25(OH)D levels, and moreover to provide a biological reservoir. The three doses are considered as comparable in efficacy and safety.

The fourth group is intended to utilize the expanded dose range of 4286 IU/ day, using the 30.000 IU tablets on a weekly dosing schedule. This group is to demonstrate the efficacy of higher doses to normalize the vitamin D levels, within a reasonable timeframe of 60-90 days.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules

NCT04476511

Vitamin D Deficiency

COMPLETED PHASE3

Pharmacokinetics of Calcifediol and Cholecalciferol

NCT02333682

Osteoporosis

COMPLETED NA

Treatment Study of Vitamin D Deficiency in Adolescents

NCT01784029

Vitamin D Deficiency

COMPLETED PHASE4

A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

NCT01650883

Vitamin D 25 OH Deficiency

COMPLETED NA

Dosage Calculation for Vitamin D Treatment

NCT02186106

Deficiency, Vitamin D Obesity

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

30000 IU cholecalcipherol once a week

30000 IU cholecalcipherol once a week oral

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

7000 IU cholecalcipherol once a week

7000 IU cholecalcipherol once a week oral

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

30000IU cholecalcipherol once a month

30000IU cholecalcipherol once a month oral

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

1000 IU cholecalciferol once a day

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cholecalciferol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Subject are included as 18 years or older ( adults) with the following specific criteria:

* 25(OH)D level \< 50 nmol/L (20 ng/ml)
* female subjects either postmenopausal status or under proper (continuous) contraception during the course of the study are allowed to be enrolled
* Subject informed willing to participate and ICF signed and dated properly

Exclusion Criteria

* hypercalcaemia/ se Ca levels out of 2.20-2.60 mmol/L range
* symptoms or lab results of elevated se Ca during the last year
* hypercalciuria within the last two years
* renal stones formation in anamnesis
* sever kidney disease ( CKD 3 or higher grade)
* chronic or serious illness that may result in malabsorption, the metabolisms of vitamin D or bones
* severe grade of metabolic diseases, bone disorders, excluded the primary age related osteoporosis,
* obesity ( BMI\>35)
* diseases that resulted in changed absorption of calcium
* CHF or angina pectoris,
* recent (\<3 month) surgical traumatic treatment
* alcohol or drug abuse,
* Vitamin D therapy or food supplements applied with the last 2 months, (at 1000 IU or above)
* planned travel (more than 5 days-long to a region of high natural UVB exposition)
* regular ( \>2 per month) artificial UVB exposition (solarium)
* permanent use of non-permitted concomitant medication

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes