ClinicalTrials.gg
Status unknownNCT04829487Updated Apr 2, 2021

The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D

An interventional study of Ergocalciferol Capsules and Placebo in Hypovitaminosis D, sponsored by Mahidol University. Status unknown. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies testing ergocalciferols in Vitamin D Deficiency — 1 open to participants now, 1 under way, none of them phase 3. Ergocalciferols · Vitamin D Deficiency.

Planned enrollment
27th of 38
36 · median 64
Started
2021
with 1 other
No phase
21 of 38
none open now
Registered
35th of 38
by date

Among the 38 studies testing ergocalciferols in Vitamin D Deficiency, this one is the 27th largest by planned enrollment, is one of 2 that started in 2021, is one of 21 with no phase, and was the 35th registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

1 of the 38 studies testing ergocalciferols in Vitamin D Deficiency is open now. Recruiting first, the newest first:

About ergocalciferols

Ergocalciferols: first FDA approval 1941 (DRISDOL). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 30 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies testing ergocalciferols in Vitamin D Deficiency, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate the effect of vitamin D supplementation on the pain score of primary dysmenorrhea. Our hypothesis is that by normalizing vitamin D level could help improve pain score of women who have primary dysmenorrhea.

Read the detailed description

This study is aimed to be conducted in randomised controlled trial, comparing between intervention group and placebo group. We include women with primary dysmenorrhea who also have low vitamin D level in this trial. Our primary outcome is to compare visual analog pain scale between intervention and placebo group after treatment. After randomised and allocated, these women will be given vitamin D 50,000 IU or placebo capsules orally weekly for 8 consecutive weeks. We monitor pain score daily from the cycle before the drugs started until complete 8-week course of the regimen mentioned. Also vitamin D levels will be monitored twice, one before treatment and the other after treatment.

03

Conditions studied

  • Hypovitaminosis D

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04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary dysmenorrhea
  • Hypovitaminosis D

Exclusion criteria

Exclusion Criteria:

  • Using calcium, magnesium or phosphorus in the past 3 months
  • Using hormonal or IUD in the past 6 months
  • No smoking or alcohol drinking
  • Chronic underlying diseases
  • Allergic to components in study drugs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Vitamin D

    Vitamin D 50,000 IU orally weekly for 8 weeks

    Drug: Ergocalciferol Capsules

  • Placebo comparator
    Placebo

    Placebo capsules orally weekly for 8 weeks

    Drug: Placebo

Interventions

  • Given to subjects 50,000 IU per week for 8 weeks

    Also known as: Vitamin D2

  • DrugPlacebo

    Placebo capsules

06

What researchers measure

Primary outcomes

  1. Visual analog pain scale

    Pain score between intervention and placebo group after treatment

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2021; primary completion for Apr 2023, 23 months later.

Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's planned 23 months is above that.

Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2021
First posted
Apr 2, 2021
StartEst.
May 1, 2021
Primary completionEst.
Apr 30, 2023
CompletionEst.
Apr 30, 2023
Last update
Apr 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04829487
Lead sponsor
Mahidol University
Responsible party
Preeyaporn Jirakittidul (Doctor, Mahidol University) — Principal investigator
First posted
Apr 2, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
Apr 2, 2021

Study contacts

Mananya Silpakit, Doctor
Contact
msilpakit@gmail.com
+66987795945
Mananya Silpakit, Doctor
principal investigator · Reproductive medicine unit, Department of OB-GYN, Faculty of Medicine, Siriraj Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ergocalciferols

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