Multicenter, Randomized, Blind and Controlled Clinical Trial to Evaluate the Efficacy and Safety in the Correction of Deficit in Subjects with Severe Vitamin D Deficiency. Dtreat Study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Itf Research Pharma S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

15 Sep 2025 → ongoing

Decision date (initial)

2024-08-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ITF RESEARCH PHARMA, S.L.U.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the efficacy in correcting 25(OH)D deficiency after 6 weeks of treatment with xxxxxx in patients with severe vitamin D deficiency, compared with xxxxxx.

Secondary objectives 12

1. To assess the efficacy in correcting 25(OH)D deficiency after 12 (Phase I+II) weeks of treatment.
2. To evaluate the efficacy in correcting 25(OH)D deficiency after 6 (Phase I) and 12 (Phase I+II) weeks of treatment, according to the following classifications (insufficiency, sufficiency, optimal levels, and maximum levels) of post-treatment 25(OH)D values: o Insufficiency: 25(OH)D values ≥ 20 ng/ml and < 30 ng/ml o Sufficiency: 25(OH)D values ≥ 30 ng/ml o Optimal levels: 25(OH)D values ≥ 30 ng/ml and ≤ 50 ng/ml o Maximum levels: > 50 ng/ml; >60 ng/ml; >80 ng/ml; >100 ng/ml; >150 ng/ml.
3. To evaluate the efficacy in maintenance after 12 weeks of treatment (Phase II) of the correction of 25(OH)D deficiency, according to the following classifications (deficiency, insufficiency, sufficiency, optimal levels, and maximum levels) of 25(OH)D values for subgroups of patients based on 25(OH)D values after 6 weeks of treatment (Phase I) [< 20 ng/mL; [20-30) ng/mL; < 30 ng/ml; ≥30 ng/ml]: o Deficiency: 25(OH)D values < 20 ng/ml o Insufficiency: 25(OH)D values ≥ 20 ng/ml and < 30 ng/ml o Sufficiency: 25(OH)D values ≥ 30 ng/ml o Optimal levels: 25(OH)D values ≥ 30 ng/ml and ≤ 50 ng/ml o Maximum levels: > 50 ng/ml; >60 ng/ml; >80 ng/ml; >100 ng/ml; >150 ng/ml.
4. To assess the change in 25(OH)D levels after 6 (Phase I) and 12 (Phase I+II) weeks of treatment from baseline and after 12 (Phase II) weeks of treatment from 6 weeks of treatment.
5. To assess the difference in plasma profile of 25(OH)D throughout the study.
6. To assess the difference in vitamin D metabolism after 6 (Phase I) and 12 (Phase I+II) weeks of treatment from baseline and after 12 (Phase II) weeks of treatment from the values after 6 weeks of treatment.
7. To evaluate the difference in other parameters of bone metabolism after 6 (Phase I) and 12 (Phase I+II) weeks of treatment compared to baseline values and after 12 (Phase II) weeks of treatment compared to values after 6 weeks of treatment.
8. To assess the treatment compliance after 6 (Phase I) and 12 (Phase II) weeks of treatment.
9. To assess the degree of satisfaction perceived by the patient and investigator with the treatment after 6 (Phase I) and 12 (Phase II) weeks.
10. To assess the degree of treatment recommendation (after 12 weeks) perceived by the investigator depending on the treatment group.
11. Description of basal calcium intake.
12. To assess the safety of treatment during the study.

Conditions and MedDRA coding

Severe vitamin D deficiency

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adults of both sexes aged ≥ 18 years.
2. Patients with severe vitamin D deficiency defined as 25(OH)D ≤ 12 ng/ml.
3. Patients with a body mass index between 18.5-34.9 kg/m2 (both included).
4. Patients who have given their written informed consent to participate in the study.

Exclusion criteria 14

1. Patients who have malabsorption syndrome or have undergone bariatric surgery.
2. Patients with severe hepatic impairment.
3. Patients with nephrolithiasis, chronic kidney disease, severe renal impairment and/or creatinine clearance < 30 mL/min.
4. Patients with a clinical history of hypercalcemia and/or hypercalciuria, or who currently have any of these diseases.
5. Patients diagnosed with primary hyperparathyroidism, hyperthyroidism, and/or hypoparathyroidism.
6. Cancer patients currently or in the 2 years prior to signing the Informed Consent.
7. Patients with sarcoidosis, tuberculosis, or other granulomatous diseases.
8. Patients on medication that has a known interaction on vitamin D absorption or metabolism in the week prior to the screening visit or who plan to initiate it during the course of the study (e.g., Antiepileptic drugs that induce the cytochrome P450 pathway, such as phenytoin and phenobarbital. Corticosteroids given long-term (> 3 months of treatment) orally or systemically, or inhaled in high doses.
9. Patients who have received a nutritional supplement or treatment containing ≥ 800 IU of vitamin D in the month prior to inclusion or plan to receive vitamin D and/or calcium supplementation/treatment during the study.
10. Patients with other diseases, alterations or on treatment with drugs (e.g. treatment with teriparatide) that, in the opinion of the investigator, may modify the development of the study.
11. Women who are pregnant or intend to become pregnant during the study intervention period and/or breastfeeding women
12. Patients with hypersensitivity to any of the active ingredients or excipients of any of the study treatments.
13. Patients who have received an investigational product within 30 days prior to inclusion in the study, or plan to do so during the course of the study.
14. Patients who, in the opinion of the investigator, are not suitable candidates to receive the investigational product, or have difficulty in comprehension, reading or writing, or any difficulty in following the requirements of the study, such as lack of adherence to the study treatment, inability to collect relevant data (demographic and/or clinical characteristics), with the exception of patients with dementia who have a legal representative.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of patients achieving 25(OH)D levels ≥ 20 ng/ml after 6 weeks of treatment.

Secondary endpoints 12

1. Percentage of patients achieving 25(OH)D levels ≥ 20 ng/ml after 12 (Phase I+II) weeks of treatment.
2. Percentage of patients achieving different levels of 25(OH)D after 6 (Phase I) and 12 (Phase I+II) weeks of treatment based on post-treatment 25(OH)D values.
3. Percentage of patients achieving different levels of 25(OH)D after 12 (Phase II) weeks of treatment, based on values of 25(OH)D after 6 weeks of treatment (Phase I).
4. Absolute and relative differences in 25(OH)D concentrations after 6 (Phase I) and 12 (Phase I+II) weeks of treatment compared to baseline values and after 12 (Phase II) weeks of treatment compared to the values of week 6.
5. Plasma 25(OH)D curves: the variable of 25(OH)D concentration will be represented at the three time points measured: baseline visit, visit 2 (after 6 weeks of treatment, Phase I) and visit 3 (after 12 weeks of treatment, Phase II and after the maintenance phase, Phase IIb).
6. Absolute and relative differences in vitamin D metabolism parameters after 6 (Phase I) and 12 (Phase I+II) weeks of treatment compared to baseline and after 12 weeks (Phase II only) of treatment compared to values after 6 weeks of treatment.
7. Absolute and relative differences and frequency of values outside the normal range of bone metabolism parameters after 6 (Phase I) and 12 weeks (Phase I+II) of treatment with respect to baseline values and after 12 weeks (Phase II only) of treatment with respect to values after 6 weeks of treatment.
8. The degree of adherence will be calculated after 6 (Phase I) and 12 (Phase II) weeks of treatment during the study period.
9. The degree of satisfaction with the treatment will be assessed by both the patient and the investigator independently at 6 (Phase I) and 12 (Phase II) weeks of treatment using a Likert-type question with 4 options: "How satisfied are you with the study medication?", possible answers: Very dissatisfied, dissatisfied, satisfied, and very satisfied.
10. The degree of treatment recommendation perceived by the investigator will be evaluated after 12 weeks of treatment through a question with a 4-choice Likert answer: "What is the degree of recommendation of the study medication?", possible answers: very positive, positive, negative and very negative. The causes of such a response should also be described, having to select one or more of the following options: efficacy, safety, pharmacokinetic profile, available clinical evidence, ease of of admin
11. Calcium intake will be assessed at baseline by the absolute value of calcium consumed per day by the patient. This value will be estimated by the SEIOMM daily calcium intake calculator.
12. The safety of treatment during the study will be assessed by the Incidence of Adverse Events and Serious Adverse Events over the entire study period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Itf Research Pharma S.L.

Sponsor organisation

Itf Research Pharma S.L.

Address

Calle De San Rafael 3, Poligono Industrial Calabozos Poligono Industrial Calabozos

City

Alcobendas

Postcode

28108

Country

Spain

Scientific contact point

Organisation

Itf Research Pharma S.L.

Contact name

Carlos Badiola Villa

Public contact point

Organisation

Itf Research Pharma S.L.

Contact name

Eva García Aguilar

Third parties 1

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications