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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021967-34 | EudraCT Number |
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Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy
An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Addition of Vitamin D to Peg-interferon plus Ribavirin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Drug | Vitamin D on top of the standard treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy | at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HCV viral load after correction of vitamin D deficiency (delta log) | at day 0 | |
| Changes in HCV viral load (delta log) | at week 4 | |
| Changes in HCV viral load (delta log) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Cacoub, MD | Pitié Salpétrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25987791 | Derived | Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| at week 12 |
| Negativity of HCV RNA below 12 UI/ml | at week 24 |
| Negativity of HCV RNA below 12 UI/ml | at week 72 |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |