Sleep Apnea Syndrome and Vitamin D
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Laboratoire Crinex
Laboratoire Cidelec
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01323218
First received: March 24, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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Purpose
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a highly prevalent disorder with multiple comorbidities.
OSAHS is characterized by repetitive episodes of airflow reduction (hypopnoea) or cessation (apnoea) due to upper airway collapse during sleep. Its major risk factor is obesity. However, its pathogenesis is complex and multifactorial. Reduced upper airway muscle tonus and/or unstable neuromuscular output seem to be involved in this collapsus.
A normal vitamin D status is necessary for normal muscle function and neuromuscular output. As obesity is associated with a high rate of hypovitaminosis D, it appears of interest to evaluate the effect of vitamin D supplementation on OSAHS patients with vitamin D deficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea-hypopnea Syndrome |
Drug: 25 OH vitamin D |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of the Correction of Vitamin D Deficiency in Patients With Obstructive Sleep Apnea-hypopopnea Syndrome (OSAHS) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- Apnea-hypopnea index (AHI), defined as the average rate of apneas and hypopneas per hour of sleep [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Epworth sleepiness scale [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- mean arterial oxygen saturation (SaO2) during sleep, time of SaO2<90%, and Nadir of arterial oxygen saturation (Nadir SaO2) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- Continuous positive airway pressure measured with a CPAP equipment [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- Muscular strength measured with handgrip test [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- Mini Mental Sate Examination, trail making test, Hamilton Anxiety Depression scale, SF36 questionnaire [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- Inflammatory status : IL6 and high sensitivity C-reactive proteine (hs CRP) [ Time Frame: at the beginning (day 0) and after 32 days of vitamin D supplementation ] [ Designated as safety issue: Yes ]
- Analysis of genes implicated in vitamin D metabolism [ Time Frame: at inclusion. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: 25 OH vitamin D
After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies
Prospective, longitudinal, double bind, randomized study of the effect of vitamin D supplementation in OSAHS patients with hypovitaminosis D.
After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate to severe obstructive sleep apnoea (AHI > 15)
- With or without continuous positive airway pressure for a minimum of six months
- aged 30-75 years
- Vitamin D2D3 level < 30 ng/ml
Exclusion Criteria:
- Diseases or therapy known to interfere with phospho-calcium or vitamin D metabolism
- Patients with mixed sleep apnoea (central and obstructive)
- Patients with CPAP use < 4 hours per night
- Patients with maxillofacial or oro-pharyngeal diseases)
- Patients with chronic respiratory failure, hypercapnic patients
- Muscle diseases
- Alcohol intake > 2 glasses per day
- Body mass index > 40 kg/m2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323218
Contacts
| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Laboratoire Crinex
Laboratoire Cidelec
More Information
No publications provided
| Responsible Party: | Patrick LACARIN, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01323218 History of Changes |
| Other Study ID Numbers: | CHU-0091 |
| Study First Received: | March 24, 2011 |
| Last Updated: | March 24, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Obstructive sleep apnea-hypopnea syndrome OSAHS Vitamin D |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Vitamin D Deficiency Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013