Can we with vitamin D, improve the immune system?

Can we with vitamin D3, improve the innate immune system?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003673-18-BE

Enrollment

100

Registered

2016-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Immunological problems such as hypogammaglobulinemia with clinical recurrent infections such as sinusitis , pneumonia , otitis , skin infections and gastrointestinal infections.

Interventions

Trade Name: D-cure Product Name: D-cure Product Code: BE461173 Pharmaceutical Form: Capsule, soft INN or Proposed INN: D-cure Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Application for a Toll-like receptor research because of immunological problems such as hypogammaglobulinemia with clinical recurrent infections such as sinusitis, pneumonia, otitis, skin infections and gastrointestinal infections. No distinction is made in this study on the gender or age. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: In case of refusal of the patient or parents. Patient with sarcoidosis or disease Besnier-Book Schaumann. Known hypersensitivity to any of the ingredients in the drug. Hypercalcemia and in particular idiopathic hypercalcemia in infants. Hypercalciuria and, in particular, when it is accompanied with renal lithiasis. Patients with renal insufficiency, lithiasis or heart disease because these patients have a higher risk of hypercalcaemia. Patients taking drugs such as digitalis preparations, thiazide diuretics, phenytoin, carbamazepine and prymidone.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?;Secondary Objective: The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?;Primary end point(s): An improvement of the immune system in the clinical field and in blood levels.;Timepoint(s) of evaluation of this end point: 1/6/2018	—

Measure

Time frame

Main Objective: The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?;Secondary Objective: The aims of this study is to find answers to some questions: 1. Can we through changes in the vitamin D state in PID (primary immune deficiency patients) with impaired Toll-Like Receptor Response trigger an immunological effect? These modifications take place by administration of vitamin D3 supplements. 2. Is there a pre-interventional connection between cholesterol or / and vitamin D level and the current Toll-like receptor activity? 3. If the patients had previously received a vitamin D treatment during their first year of life, then has this an influence on the current status of vitamin D? 4. Is there post-interventional a noticeable difference compared to pre-interventional in total cholesterol or / and vitamin D levels?;Primary end point(s): An improvement of the immune system in the clinical field and in blood levels.;Timepoint(s) of evaluation of this end point: 1/6/2018

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Secondary

Measure	Time frame
Secondary end point(s): Vitamine D given in beginning of life has an advantage on the current immune system.;Timepoint(s) of evaluation of this end point: 1/6/2018	—

Countries

Belgium

Contacts

Public ContactPediatrie Hematologie/oncologie

UZ Brussel

jvdwerff@uzbrussel.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026