Effect of a six-month vitamin D supplementation on depressive symptoms in patients with major depressive episode (DepFuD): a double-blinded randomised controlled trial
Mikola T, Lehto SM, Tolmunen T, Honkalampi K, Valkonen-Korhonen M, Laukkanen V, Pakarinen M, Koivumaa-Honkanen H, Ruusunen A
Journal of affective disorders · 0 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Itä-Suomen Yliopisto
- Organización sin fines de lucro
- Suomen Lääketieteen Säätiö
- Organización sin fines de lucro
- Juho Vainion Säätiö
- Organización sin fines de lucro
- Finnish Medical Foundation
- Organización sin fines de lucro
- Juho Vainio Fundation
- Universidad u hospital
- University of Eastern Finland
Según 6 financiadores declarados.
Publicación
- Publicado
- 2026-03-31 · J Affect Disord · vol. 406 · pág. 121709
- Editorial
- Elsevier BV
- Citado
- 0 citas · más que el 20% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 33 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Treatment of Major Depression · Tryptophan and brain disorders
- Palabras clave
- vitamin D supplementation, major depressive disorder, depressive symptoms, vitamin D3, vitamin D deficiency, adjunctive therapy, Montgomery-Asberg Depression Rating Scale
- MeSH
- humans, vitamins, vitamin d, treatment outcome, double-blind method, psychiatric status rating scales, dietary supplements, adolescent, adult, aged, middle aged, finland, female, male, young adult, major depressive disorder
9 autores
- Tuomas Mikola🇫🇮 · autor de correspondenciaUniversity of Eastern Finland
- Soili Marianne Lehto🇫🇮🇳🇴University of Helsinki; University of Oslo; Akershus University Hospital
- Tommi Tolmunen🇫🇮University of Eastern Finland; Kuopio University Hospital
- Kirsi M. Honkalampi🇫🇮University of Eastern Finland
- Minna Valkonen‐Korhonen🇫🇮University of Eastern Finland; Kuopio University Hospital
- Virpi Laukkanen🇫🇮University of Eastern Finland; Kuopio University Hospital
- Maarit Pakarinen🇫🇮University of Eastern Finland; Kuopio University Hospital
- Heli T. Koivumaa-Honkanen🇫🇮University of Eastern Finland
- Anu A. Ruusunen🇦🇺🇫🇮Barwon Health; Deakin University; University of Eastern Finland; Kuopio University Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Initial studies suggest vitamin D (VD) supplementation may aid in treating major depressive disorder, but rigorous randomised controlled trials are needed.
Trial design
DepFuD trial was a six-month, double-blinded, parallel-group, randomised controlled superiority design trial with a 1:1 allocation ratio. Outpatients with mild to severe depression episode, aged 18-65 years, were included.
Methods
The primary aim was to compare the effects of low-dose versus high-dose VD as adjunctive to participants' existing depression treatments, hypothesising that the high-dose group would show greater symptom reduction over six months. Participants were randomised to receive either 100 μg (4000 IU) or 10 μg (400 IU) of VD (cholecalciferol) daily for six months. The primary outcome was measured by between-group differential change over six months in the Montgomery-Åsberg Depression Rating Scale (MADRS) score (range: 0-60). Data was collected in Finland between November 2015 and December 2020.
Results
A total of 281 participants were randomised: 142 in the low-dose and 139 in the high-dose group. At baseline, 46% of the participants in low-dose and 42% in high-dose group had VD deficiency (<50 nmol/l). Primary outcome data were available for 234 participants (116 in low-dose and 118 in high-dose). The standardised adjusted MADRS mean difference was small and non-significant (Cohen's d = -0.09; 95% CI -0.32 to 0.14).
Conclusions
The six-month trial demonstrated no superior effect of the higher VD supplementation compared to the lower VD supplementation on depressive symptoms.
Registration
ClinicalTrials.gov: NCT02521012. DepFuD was supported by Finnish State Research Funding (VTR).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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