Vitamin DNEW2026-10

Vitamin D Supplementation and Improvement in Insomnia Symptoms Among Malaysian Women With Vitamin D Deficiency: Protocol for a Randomized Controlled Trial.

Puspitasari Rara Merinda, Mohamad Noor Zaswiza, Setiawan Didik, Ibrahim Norkasihan — JMIR research protocols

Summary

This study is designed to explore whether taking vitamin D supplements can improve sleep problems like insomnia in Malaysian women who are deficient in vitamin D. Researchers will compare a vitamin D group to a placebo group to see if supplementation leads to better sleep quality and reduced insomnia symptoms. The findings could suggest a new way to support sleep health.

AI-generated summary — read the original

Key points

This study is investigating if vitamin D supplements can help improve insomnia symptoms in Malaysian women with low vitamin D levels.
It's a randomized controlled trial, meaning some participants will get vitamin D and others a placebo, to ensure fair comparison.
The research aims to measure changes in sleep quality, insomnia severity, and daily functioning.
If effective, vitamin D supplementation might become a complementary approach for managing insomnia.

What the study looked at

What question the study asked: This research project aims to investigate whether taking vitamin D supplements can help improve sleep problems, specifically insomnia, in Malaysian women who have low levels of vitamin D. Previous studies have hinted at a link between vitamin D deficiency and sleep issues, especially in women, but more clear evidence is needed, particularly in Southeast Asian populations. How it was studied: To answer this question, researchers are conducting a carefully designed study. They are recruiting women aged 19 to 50 in Malaysia who have both vitamin D deficiency and symptoms of insomnia. Participants are randomly assigned to one of two groups: one group receives a weekly vitamin D supplement (50,000 IU), and the other receives a placebo (an inactive pill) for nine weeks. Neither the participants nor the researchers know who is receiving which treatment. Various measures of sleep quality, insomnia severity, and daily functioning are being collected throughout the study. What it found: This paper describes the detailed plan for the study, which is currently in progress. Participant recruitment began in late 2023 and is expected to continue until late 2026. As of mid-2026, a number of participants have been screened and enrolled, with some having completed the intervention. The full results of this randomized controlled trial are not yet available, but they are anticipated to provide valuable insights into the potential role of vitamin D in managing insomnia.

Dietary takeaway

While this study's results are still pending, it highlights the ongoing interest in vitamin D's role in overall health, including sleep. Ensuring adequate vitamin D intake through fortified foods like milk and cereals, fatty fish like salmon, or safe sun exposure is generally beneficial. Remember, this is just one study's protocol, and definitive dietary recommendations for insomnia based on vitamin D would require more completed research.

Abstract

BACKGROUND: Insomnia is a prevalent sleep disorder associated with adverse physical, psychological, and functional outcomes. Emerging evidence suggests that vitamin D deficiency may contribute to sleep disturbances. Women are more likely to have lower serum vitamin D (25-hydroxyvitamin D [25(OH)D]) levels than men, and they also report a higher prevalence of insomnia. Although several studies have proposed that vitamin D supplementation may improve insomnia symptoms, findings remain inconsistent, and evidence from Southeast Asian populations is limited. OBJECTIVE: This study aims to evaluate the effectiveness of weekly vitamin D₃ supplementation in improving insomnia symptoms, sleep quality, sleep efficiency, and functional outcomes among Malaysian women with vitamin D deficiency. METHODS: This study is a double-blind, parallel-group, randomized placebo-controlled trial conducted among women aged 19-50 years with serum 25(OH)D levels <20 ng/mL and insomnia symptoms. Participants are randomized to receive either vitamin D₃ capsules (50,000 IU/wk) or placebo (1 capsule/wk) for 9 weeks. The study is conducted in a community setting. Primary outcomes include insomnia severity assessed using the Insomnia Severity Index (ISI), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), and sleep efficiency objectively assessed using actigraphy. Secondary outcomes include daytime sleepiness measured using the Epworth Sleepiness Scale (ESS) and functional outcomes assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). Assessments are conducted at baseline, midintervention, and postintervention. RESULTS: Participant recruitment commenced in December 2023 and is expected to conclude in December 2026. As of July 2026, 42 participants had been screened, 33 eligible participants had been enrolled, 22 had completed the study procedures, 4 were in the intervention phase, and 1 had withdrawn due to loss of contact. CONCLUSIONS: If the efficacy of vitamin D3 supplementation in alleviating insomnia symptoms is demonstrated, it might be proposed as a supplementary approach to cognitive behavioral therapy (CBT) for insomnia. Screening for vitamin D deficiency may also be considered in individuals presenting with insomnia symptoms prior to initiating pharmacological treatment.

View on PubMed →DOI: 10.2196/63804