Vitamin D DeficiencyPhase 4NCT05276960
Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF
A Phase 4 study testing Cholecalciferol Pill in people with Vitamin D Deficiency and Cystic Fibrosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
Cystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Vitamin D Deficiency, Cystic Fibrosis, Bone Density, Low
- What is being tested?
- Cholecalciferol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 22 Jun 2022to 30 Jan 2025
- Phase
- Phase 4
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cystic Fibrosis
Who cannot join
- Another chronic disease (HIV, cancer, renal failure)
- 25-OH-VitD levels < 10 ng/ml or > 30 ng/ml
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, 06700
About this study
Official title: A Randomized, Double-blind Study of the Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum Vitamin D Levels in Pediatric Patients With Cystic Fibrosis
Cystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. In addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin D.
Vitamin D, in addition to its role in bone health, in the case of CF patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin D, so vitamin D could play an essential role in the regulation of the inflammatory response in CF, which could favor lung function.
However, more than 50% of CF patients present vitamin D insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin D levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.
Read the detailed description
Randomized double-blind clinical trial in patients aged 5 to 18 years attending the CF Comprehensive Care clinic in Mexico City. The intervention group will receive an intensification of vitamin D supplementation, with increments of 4000 IU depending on serum levels, the control group will receive supplementation according to the treatment guidelines of the Cystic Fibrosis Foundation, and the dose will be doubled depending on serum levels. In both groups vitamin D levels will be measured at 3, 6, 9, and 12 months, spirometry and sputum culture will also be performed to evaluate the pulmonary function, densitometry to evaluate the bone mineral density and body composition, together with anthropometric evaluation and quantitative bone ultrasound at each visit, in the biochemical evaluation, calcium/creatinine ratio and alkaline phosphatase will be taken at each visit.
- Conditions
- Vitamin D Deficiency, Cystic Fibrosis, Bone Density, Low, Inflammation Chronic, Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation
- Being tested
- Cholecalciferol Pill
- Keywords
- vitamin D, cystic fibrosis, pulmonary exacerbation, Vitamin D Deficiency or insufficiency
- Medical subject headings
- Vitamin D Deficiency, Cystic Fibrosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol PillDrug
Dose increments according to serum levels determined every 2 months
| Study group | Role | What they receive |
|---|---|---|
| Regular supplementation | Active comparator | Baseline dose of 2000 IU of vitamin D3, based on Cystic Fibrosis Foundation (CFF) treatment guidelines. According to serum vitamin D levels, 2000 IU increments will be performed whenever 25-OH-VitD (25-hydroxy vitamin D) values < 30 ng/ml are found. Receives: Drug: Cholecalciferol Pill |
| Enhanced Supplementation | Experimental | Basal dose of 4000 IU of vitamin D3. According to serum vitamin D levels, increments of 4000 IU will be made each time 25-OH-VitD values < 30 ng/ml are found. Receives: Drug: Cholecalciferol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VitD Levels
Serum vitamin D levels up to 30 ng/ml
Measured: Baseline, every 2 months through study completition, an avarage of 1 year.
Secondary outcomes (2)
Changes in the number of Pulmonary exacerbations
Number of exacerbations present during 1 year prior and 1 year after the baseline
Measured: 12 months
Changes in the Bone mineral density
changes in bone mineral content at baseline and at the end of the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start22 Jun 2022
- Primary completion30 Aug 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric CF patients will be recruited from the CF Integrated Care Clinic of the Federico Gomez Children's Hospital of Mexico. Once at the clinic they will be invited to participate in the study. Parents or guardians of patients under 8 years of age will be asked to sign the informed consent form before starting the studies, procedures and intervention. For those patients older than 8 years, in addition to parental consent, they will be given information and asked to sign the informed consent form before starting the studies, procedures, and intervention. The restrictive randomization will be performed by blocks of 8,obtained through the web page https://www.randomizer.org/, and will be carried out by one of the investigators, who will also be responsible for its safekeeping. The concealment will be carried out by the same investigator in charge of the randomization, for which the treatment groups will be placed in metallic gray, non-transparent, previously labeled envelopes
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magali Reyes Apodaca, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Magali R Reyes Apodaca, MSc, Principal investigator, Hospital Infantil de Mexico Federico GomezMara Medeiros, MD, Msc, PhD, Study director, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276960
- Sponsor's protocol ID
- HIM-2021-087
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum Vitamin D Levels in Pediatric Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05276960
- Acronym / sponsor ID
- HIM-2021-087
- Conditions
- Vitamin D Deficiency, Cystic Fibrosis, Bone Density, Low, Inflammation Chronic, Cystic Fibrosis in Children, Cystic Fibrosis Pulmonary Exacerbation
- Keywords
- vitamin D, cystic fibrosis, pulmonary exacerbation, Vitamin D Deficiency or insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. In addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin D.
Vitamin D, in addition to its role in bone health, in the case of CF patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin D, so vitamin D could play an essential role in the regulation of the inflammatory response in CF, which could favor lung function.
However, more than 50% of CF patients present vitamin D insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin D levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.
Detailed description
Randomized double-blind clinical trial in patients aged 5 to 18 years attending the CF Comprehensive Care clinic in Mexico City. The intervention group will receive an intensification of vitamin D supplementation, with increments of 4000 IU depending on serum levels, the control group will receive supplementation according to the treatment guidelines of the Cystic Fibrosis Foundation, and the dose will be doubled depending on serum levels. In both groups vitamin D levels will be measured at 3, 6, 9, and 12 months, spirometry and sputum culture will also be performed to evaluate the pulmonary function, densitometry to evaluate the bone mineral density and body composition, together with anthropometric evaluation and quantitative bone ultrasound at each visit, in the biochemical evaluation, calcium/creatinine ratio and alkaline phosphatase will be taken at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Pediatric CF patients will be recruited from the CF Integrated Care Clinic of the Federico Gomez Children's Hospital of Mexico. Once at the clinic they will be invited to participate in the study. Parents or guardians of patients under 8 years of age will be asked to sign the informed consent form before starting the studies, procedures and intervention. For those patients older than 8 years, in addition to parental consent, they will be given information and asked to sign the informed consent form before starting the studies, procedures, and intervention. The restrictive randomization will be performed by blocks of 8,obtained through the web page https://www.randomizer.org/, and will be carried out by one of the investigators, who will also be responsible for its safekeeping. The concealment will be carried out by the same investigator in charge of the randomization, for which the treatment groups will be placed in metallic gray, non-transparent, previously labeled envelopes
| Arm | Type | Receives |
|---|---|---|
| Regular supplementation | Active comparator | Drug: Cholecalciferol PillBaseline dose of 2000 IU of vitamin D3, based on Cystic Fibrosis Foundation (CFF) treatment guidelines. According to serum vitamin D levels, 2000 IU increments will be performed whenever 25-OH-VitD (25-hydroxy vitamin D) values < 30 ng/ml are found. |
| Enhanced Supplementation | Experimental | Drug: Cholecalciferol PillBasal dose of 4000 IU of vitamin D3. According to serum vitamin D levels, increments of 4000 IU will be made each time 25-OH-VitD values < 30 ng/ml are found. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Cystic Fibrosis
Key exclusion criteria (2 listed)
- Another chronic disease (HIV, cancer, renal failure)
- 25-OH-VitD levels < 10 ng/ml or > 30 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol PillDose increments according to serum levels determined every 2 months | Drug | Enhanced Supplementation, Regular supplementation |
Primary outcome
Change in VitD Levels
Time frame: Baseline, every 2 months through study completition, an avarage of 1 year.
Serum vitamin D levels up to 30 ng/ml
2 secondary outcomes
Changes in the number of Pulmonary exacerbations
Time frame: 12 months
Changes in the Bone mineral density
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magali R Reyes Apodaca, MSc principal investigator
Hospital Infantil de Mexico Federico Gomez
Mara Medeiros, MD, Msc, PhD study director
Hospital Infantil de Mexico Federico Gomez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol Pill in people with Vitamin D Deficiency and Cystic Fibrosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
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 2 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 8 Apr 2025. 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 Mexico. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in VitD Levels (time frame: Baseline, every 2 months through study completition, an avarage of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.