ClinicalTrials.gg
CompletedNCT05376865Updated May 17, 2022

Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers

An interventional study of Vitamin D supplement in Overweight and Hypovitaminosis D, sponsored by Tirang R. Neyestani, Ph.D.. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Tirang R. Neyestani, Ph.D. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2021, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Where this study stands

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

Among 19 studies in Overweight with a site in Iran, Islamic Republic of — 1 open to participants now, 1 under way, none of them phase 3. Overweight · Iran, Islamic Republic of.

Enrollment
18th of 19
46 · median 81
Started
2021
the only one that year
No phase
18 of 19
1 open now
Registered
18th of 19
by date
Lead sponsor
1 of 19
Tirang R. Neyestani, Ph.D.

Among the 19 studies in Overweight with a site in Iran, Islamic Republic of, this one is the 18th largest by enrollment, is the only one that started in 2021, is one of 18 with no phase, and was the 18th registered.

Overweight

3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.

Browse Overweight studies →

Open to participants now

1 of the 19 studies in Overweight with a site in Iran, Islamic Republic of is open now. Recruiting first, the newest first:

A study can be open while its sites in Iran, Islamic Republic of have not opened yet or have stopped. Only those recruiting at a site in Iran, Islamic Republic of →

Who these studies take

Of the 529 Overweight studies recruiting now, 158 (30%) set no upper age limit and 343 (65%) stop at 75 or younger; 62 take children under 18; 204 take healthy volunteers.

This study: 20 Years to 50 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 19 studies in Overweight with a site in Iran, Islamic Republic of, or all of them as a file.
02

Study summary

46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.

Read the detailed description

For the randomized controlled clinical trial (RCT), the first fifty eligible women were assigned to either the vitamin D or placebo group using the block randomization method. Each Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) contained 50000 IU cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin D deficiency. Placebo pearls (Zahravi Pharma Co, Tabriz, Iran) had the identical appearance, taste, and smell as the vitamin D pearls and could only be identified by the package code. The placebo pearls were administered similarly. To keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. Participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. They were also asked to inform the researcher before taking any new medications. All participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. The nutrigenetic study investigated 75 eligible women (including the vitamin D group and the last fifty women who entered the study). The nutrigenetic study protocol was the same as that mentioned above for the vitamin D group in the RCT. Compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. In addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. Pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended.

During the first and last visits, anthropometric and laboratory assessments were performed for all subjects. The primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis D.

03

Conditions studied

  • Overweight
  • Hypovitaminosis D
04

Who can participate

Ages eligible
20 Years to 50 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

  • low serum vitamin D level \<30ng/ml
  • 25\<\<30 kg/m2
  • Age: 20-50
  • Free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months

Exclusion criteria

Exclusion Criteria:

  • Getting pregnant during the study
  • Suffering from thyroid disorders and other diseases mentioned during the study
  • Not taking supplements weekly
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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

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

Study arms

  • Experimental
    Intervention

    Vitamin D3 supplement every week

    Dietary Supplement: Vitamin D supplement

  • Placebo comparator
    Control

    Placebo every week

    Dietary Supplement: Vitamin D supplement

Interventions

  • Dietary supplementVitamin D supplement

    The intervention group receives 50000 IU of vitamin D every week as vitamin D supplements for 12 weeks, provided monthly.

06

What researchers measure

Primary outcomes

  1. Serum 25(OH)D

    Fasting serum 25-hydroxyvitamin D level

    Time frame: 12 weeks

  2. Weight

    Subject's weight wearing light clothing

    Time frame: 12 weeks

Secondary outcomes

  1. Waist circumference

    the measurement at the midpoint between the lowest rib and the iliac crest

    Time frame: 12 weeks

  2. Fat mass

    Total body fat mass measured by Bioelectrical Impedance analysis method

    Time frame: 12 weeks

  3. Serum Fasting Glucose

    Fasting serum glucose level

    Time frame: 12 weeks

  4. Serum total cholesterol

    Fasting serum total cholesterol level

    Time frame: 12 weeks

  5. Serum triglyceride

    Fasting serum triglyceride level Fasting serum triglyceride leve

    Time frame: 12 weeks

  6. Serum hsCRP

    Fasting serum high sensitivity c-reactive protein level

    Time frame: 12 weeks

  7. Serum IL-6

    Fasting serum Interleukin-6 level

    Time frame: 12 weeks

  8. Serum TNF-a

    Fasting serum tumor necrosis factor alpha level

    Time frame: 12 weeks

  9. Serum PTH

    Fasting serum parathyroid hormone level

    Time frame: 12 weeks

07

Study locations

1 site
  • Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
    Tehran, Iran, Islamic Republic of
08

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

Ran from Sep 2021 to primary completion in Dec 2021, 3 months.

Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 3 months is below that.

Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.

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

Registered
May 11, 2022
First posted
May 17, 2022
StartActual
Sep 29, 2021
Primary completionActual
Dec 29, 2021
CompletionActual
Feb 20, 2022
Last update
May 17, 2022
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 May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05376865
Lead sponsor
Tirang R. Neyestani, Ph.D.
Responsible party
Tirang R. Neyestani, Ph.D. (Prof., National Nutrition and Food Technology Institute) — Sponsor-investigator
First posted
May 17, 2022
Start date
Sep 29, 2021
Primary completion
Dec 29, 2021
Completion
Feb 20, 2022
Last update
May 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Vitamin D

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