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Clinical care of patients with CF changed following COVID-19 pandemic (OGTT not performed at the CF clinic since March 2020); in consequence, this study is no longer feasible.
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| Name | Class |
|---|---|
| Université de Montréal | OTHER |
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Cystic fibrosis (CF) patients are at risk for vitamin K deficiencies. Supplementation for fat-soluble vitamins A, D, and E is well established, but in CF, there is little data for vitamin K concerning the optimal dose and frequency of supplementation. Beyond its known role in coagulation, research has highlighted the role of vitamin K for bone health and the control of blood sugar levels. However, after pulmonary complications, the risk of diabetes and bone diseases are two important and frequent complications of CF. Patients with CF being at risk of vitamin K deficiencies, this vitamin could play a role in these complications.
The investigators propose a pilot study (carried out to assess its feasibility on a larger scale) to evaluate if a supplement of vitamin K improves vitamin K serum levels in CF patients by comparing:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K supplement, dose #1 | Active Comparator | Vitamin K supplementation with dose #1 |
|
| Vitamin K supplement, dose #2 | Active Comparator | Vitamin K supplementation with dose #2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K supplementation, dose #1 | Dietary Supplement | Vitamin K supplement : 2mg, once a day, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum vitamin K levels from baseline at 6 months | Impact of supplementation on vitamin K serum levels | 0, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in osteocalcin levels from baseline at 6 months | Impact of supplementation on osteocalcin levels (Total and uncarboxylated) | 0, 3 and 6 months |
| Patient's perception and side effects of the supplement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, MD, PhD | Montreal Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Clinical Research Institute (IRCM) | Montreal | Quebec | H2W1R7 | Canada | ||
| CHUM |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Vitamin K supplementation, dose #2 | Dietary Supplement | Vitamin K supplement : 7mg, twice a week, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire. |
|
Visual analogue scale questionnaire
| 6 months |
| Bone marker levels | Impact of supplementation on bone marker C-Telopeptide | 0, 3 and 6 months |
| Glycemic marker levels | Impact of supplementation on HbA1c levels and fructosamine levels | 0, 3 and 6 months |
| Montreal |
| Quebec |
| Canada |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |