- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01410084
Improving Vitamin D Status in Home-bound Elders (MOW VitD)
Improving Vitamin D Status in Home-bound Elders: a Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. The investigators will accomplish this goal by conducting a 5-month randomized, controlled trial in 200 older Meals-on-Wheels (MOW) recipients randomized to receive monthly either (1) 100,000 IU vitamin D3 or (2) an active placebo (vitamin E) to achieve the following specific aims:
Aim 1: Determine the prevalence of falls and risk of vitamin D insufficiency in 200 MOW recipients.
Aim 2: Assess the feasibility of the vitamin D intervention delivered through the MOW program.
Aim 3: Obtain preliminary data on the effectiveness of the intervention on improving vitamin D status and reducing falls.
Data from this pilot study will: 1) provide estimates of the prevalence of falls and vitamin D insufficiency in home-bound older adults participating in the Forsyth County MOW program; 2) provide estimates of participant compliance and drop-out to a vitamin supplementation trial delivered as part of the MOW program; 3) provide evidence for the efficacy of the vitamin D dose proposed in remediating vitamin D insufficiency; and 4) provide preliminary data on the potential benefit of vitamin D supplementation on falls in a home-bound older population.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥ 65 years old
- Forsyth County Senior Services Meals-on-Wheels recipient
- Willing to provide informed consent
- Willing to be randomized to vitamin D or active placebo control
Exclusion Criteria:
- Hyperparathyroidism
- Kidney stones (within the past 2 years)
- History of hypercalcemia
- On dialysis
- Inability or contraindications to consume vitamin D supplements
- Taking prescription vitamin D2 or vitamin D3-containing supplements totaling > 1000 IU/d
- Planning to move within the next 6 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Vitamin D3
100,000 IU vitamin D3 once monthly
|
100,000 IU vitamin D3 once monthly for 5 months
|
|
Comparateur placebo: Vitamin E
400 IU vitamin E once monthly
|
400 IU vitamin E once monthly for 5 months
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in 25-hydroxyvitamin D Levels Over 5 Months
Délai: 5 months
|
Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up).
Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level.
|
5 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Falls
Délai: 5 months
|
Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months)
|
5 months
|
|
Number of Participants Who Were Compliant to Intervention
Délai: 5 months
|
Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months.
|
5 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Denise K Houston, PhD, Wake Forest University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles nutritionnels
- Avitaminose
- Maladies de carence
- Malnutrition
- Carence en vitamine D
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents protecteurs
- Micronutriments
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Antioxydants
- Vitamine D
- Cholécalciférol
- Vitamine E
- Vitamines
Autres numéros d'identification d'étude
- IRB00014152
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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