Vitamin D supplementation and improvement of insomnia symptoms among vitamin D deficient Malaysian women

Vitamin D supplementation and improvement of insomnia symptoms among vitamin D deficient Malaysian women: a double-blind randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN69678101

Enrollment

Registered

2024-10-01

Start date

2023-01-01

Completion date

Unknown

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of insomnia symptoms among vitamin D deficient Malaysian women Mental and Behavioural Disorders

Interventions

This study is a double-blind, randomised, placebo-controlled trial, employs one intervention group and one control group, designed in a parallel group. This superiority trial aims to demonstrate that

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Woman 2. Aged 19 - 50 years old. 3. Serum 25(OH)D level of <20 ng/mL (50 nmol/L) 4. PSQI score of =5 5. Not pregnant or lactating 6. Not sleeping with infant (< 2 years) 7. Currently (consider from the past 3 months) is not taking vitamin D or any supplements containing vitamin D 8. Not a smoker and/or alcoholic

Exclusion criteria

Exclusion criteria: Participants are excluded based on whether they have the following causes or risk factors that may contribute to insomnia: 1. Currently having the following conditions: 1.1. Malabsorption 1.2. Chronic diseases (diabetes, hypertension, cardiovascular disease etc). 1.3. Osteoporosis and/or other bone diseases 1.4. Malignancy 1.5. Hypo-or hyperthyroidism 1.6. Psychological-related illness (such as depression and anxiety) 2. Taking the following medications: 2.1. Corticosteroids 2.2. Anticonvulsant 2.3. Narcotics and psychotropics (such as antidepressants and antipsychotics). 2.4. Antiretroviral drugs 2.5. Cytotoxic agents 2.6. Antihistamines

Design outcomes

Primary

Measure	Time frame
1. Participant’s Vitamin D level status is measured using biochemistry test (Radioimmunoassay) at baseline and at the end of study (end of week 10) 2. Changes in sleepiness severity is measured using Insomnia Severity Index (ISI) questionnaire at baseline, week 5 and end of week 10 3. Sleep quality is measured using Pittsburgh Sleep Quality Index (PSQI) questionnaire at baseline, week 5 and end of week 10 4. Subjective daytime sleepiness is measured using The Epworth Sleepiness Scale (ESS) questionnaire at baseline, week 5 and end of week 10 5. Sleep pattern and sleep efficiency is measured using Actigraph (ActiTrust-2) at baseline and at the end of study (end of week 10)	—

Measure

Time frame

1. Participant’s Vitamin D level status is measured using biochemistry test (Radioimmunoassay) at baseline and at the end of study (end of week 10) 2. Changes in sleepiness severity is measured using Insomnia Severity Index (ISI) questionnaire at baseline, week 5 and end of week 10 3. Sleep quality is measured using Pittsburgh Sleep Quality Index (PSQI) questionnaire at baseline, week 5 and end of week 10 4. Subjective daytime sleepiness is measured using The Epworth Sleepiness Scale (ESS) questionnaire at baseline, week 5 and end of week 10 5. Sleep pattern and sleep efficiency is measured using Actigraph (ActiTrust-2) at baseline and at the end of study (end of week 10)

—

Secondary

Measure	Time frame
Daytime function is measured using Functional Outcomes of Sleep Questionnaire (FOSQ-10) questionnaire at baseline, week 5 and end of week 10	—

Countries

Malaysia

Contacts

Public ContactRara Merinda Puspitasari

raramerinda@unikl.edu.my+60 1139796985

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026