BridgeMD
VitDM3BH Study
EU CTIS ID: 2024-518897-15-00
What this study is testing
The overall aim of this project is to investigate the influence of high-dose short-term vitamin D3 supplementation on soft tissue wound healing after wisdom tooth extraction (third molar, M3).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: 18 to 50 years
- Gender: female/male
- Patients with insufficient serum 25(OH)D3 levels: <75 nmol/l (<30ng/ml) According to a recently published study from Germany, the prevalence of vitamin D3 deficiency, classified as serum 25(OH)D3 levels <50 nmol/l (20 ng/ml) is 60-75% in winter and 30-45% in summer. Hence, we expect a sufficient number of participants corresponding to the inclusion criteria (serum 25(OH)D3 levels <75 nmol/l (30ng/ml)
- Generally healthy Caucasian
- Indication for bilateral wisdom tooth extraction from physiologically positioned wisdom teeth in the upper jaw
- Patients who are able to follow the instructions of the X-ray technologist
You likely can't join if
- Known allergies/intolerances against any ingredients of the IMP
- Pregnant/lactating women
- Current or former smokers
- Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the surgeons or periodontists, might confound the results of the study or poses an additional risk to the subject during participation in the study o Renal insufficiency o Primary hyperparathyroidism o Malignancy o Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …) o Diabetes mellitus o Obesity class III (body mass index, BMI ≥40) o Medical conditions requiring daily calcium or antacid use o Medical conditions that result in a high calcium level in the blood or increased calcium excretion in the urine (e.g. as with treatment with certain medicines [benzothiazine derivates]
- Current or previous treatments / therapies, including o Anticoagulants o Immunosuppressive therapy o Systemic antibiotics (within the last 3 months) o Chronic use of non-steroidal anti-inflammatory drugs, aspirin and corticosteroids o Vitamin, mineral or herbal preparations or food supplements (within the last 3 months) o Rifampicin or isoniazid (against tuberculosis). Tuberculosis will be regarded as a severe pathology, and thus, patients will not be included in the study.
See the full eligibility criteria
- Age: 18 to 50 years
- Gender: female/male
- Patients with insufficient serum 25(OH)D3 levels: <75 nmol/l (<30ng/ml) According to a recently published study from Germany, the prevalence of vitamin D3 deficiency, classified as serum 25(OH)D3 levels <50 nmol/l (20 ng/ml) is 60-75% in winter and 30-45% in summer. Hence, we expect a sufficient number of participants corresponding to the inclusion criteria (serum 25(OH)D3 levels <75 nmol/l (30ng/ml)
- Generally healthy Caucasian
- Indication for bilateral wisdom tooth extraction from physiologically positioned wisdom teeth in the upper jaw
- Patients who are able to follow the instructions of the X-ray technologist
- Given written informed consent form for participation in the study
- Known allergies/intolerances against any ingredients of the IMP
- Pregnant/lactating women
- Current or former smokers
- Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the surgeons or periodontists, might confound the results of the study or poses an additional risk to the subject during participation in the study o Renal insufficiency o Primary hyperparathyroidism o Malignancy o Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …) o Diabetes mellitus o Obesity class III (body mass index, BMI ≥40) o Medical conditions requiring daily calcium or antacid use o Medical conditions that result in a high calcium level in the blood or increased calcium excretion in the urine (e.g. as with treatment with certain medicines [benzothiazine derivates]
- Current or previous treatments / therapies, including o Anticoagulants o Immunosuppressive therapy o Systemic antibiotics (within the last 3 months) o Chronic use of non-steroidal anti-inflammatory drugs, aspirin and corticosteroids o Vitamin, mineral or herbal preparations or food supplements (within the last 3 months) o Rifampicin or isoniazid (against tuberculosis). Tuberculosis will be regarded as a severe pathology, and thus, patients will not be included in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.