ClinicalTrials.gg
CompletedNCT03310307Updated Oct 16, 2017

Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

A Phase 2 interventional study of Vit D and Placebo in Homocystinaemia and Vitamin D Deficiency, sponsored by Al-Balqa Applied University. Completed at 1 site in Jordan. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Al-Balqa Applied University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2016, registered Oct 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Where this study stands

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

Among 154 studies testing Vitamin D in Vitamin D Deficiency — 15 open to participants now, 16 under way, none of them phase 3. Vitamin D · Vitamin D Deficiency.

Enrollment
57th of 153
100 · median 75
Started
2016
with 12 others
Phase 2
14 of 154
1 open now
Registered
92nd of 154
by date

Among the 154 studies testing Vitamin D in Vitamin D Deficiency, this one is the 57th largest by enrollment of the 153 interventional ones that give a count, is one of 13 that started in 2016, is one of 14 in phase 2, and was the 92nd 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

15 of the 154 studies testing Vitamin D in Vitamin D Deficiency are open now, in 8 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

All 15 open studies →

About Vitamin D

No approval found in the FDA or EMA files read. 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 49 Years · female · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 154 studies testing Vitamin D in Vitamin D Deficiency, or all of them as a file.
02

Study summary

100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.

03

Conditions studied

  • Homocystinaemia
  • Vitamin D Deficiency

Keywords

  • Homocysteine
  • Overweight
  • vitamin D3
  • Reproductive women
  • RCT
04

Who can participate

Ages eligible
18 Years to 49 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

  • Overweight ( between 25-29.99 kg/m2)
  • Had 25(OH)D \< 20 ng/mL
  • Had normal vitamin B-12 and folic acid levels
  • Not diagnosed with any chronic diseases
  • Agreed to participat in the study

Exclusion criteria

Exclusion Criteria:

  • age \< 18 or > 49 years
  • > 30 kg/m2 or \< 25 kg/m2
  • 25 (OH)D level > 20 ng/ml
  • tHcy levels greater than 100 µmol/L
  • Abnormal vitamin B-12 or folic acid levels
  • Chronic diseases
  • Pregnant or lactating
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
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    vitamin D3

    50,000 IU

    Drug: Vit D

  • Placebo comparator
    Placebo

    Similar in size, shape and color to vitamin D3

    Other: Placebo

Interventions

  • DrugVit D

    50,000 IU

    Also known as: Biodal

  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. 25(OH)D3

    vitamin D in serum

    Time frame: 2 months

Secondary outcomes

  1. Homocysteine

    serum total homocysteine

    Time frame: 2 months

07

Study locations

1 site
  • King Abdullah University Hospital
    Irbid, Jordan
08

References and documents

Publications

  • Al-Bayyari N, Al-Zeidaneen S, Hailat R, Hamadneh J. Vitamin D3 prevents cardiovascular diseases by lowering serum total homocysteine concentrations in overweight reproductive women: A randomized, placebo-controlled clinical trial. Nutr Res. 2018 Nov;59:65-71. doi: 10.1016/j.nutres.2018.07.012. Epub 2018 Jul 29. PubMed 30442234 ↗
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

Ran from Apr 2016 to primary completion in Aug 2016, 4 months.

Of 18 phase 2 interventional studies under Vitamin D Deficiency, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 45. This study's 4 months is below that.

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

Registered
Oct 11, 2017
First posted
Oct 16, 2017
StartActual
Apr 1, 2016
Primary completionActual
Aug 30, 2016
CompletionActual
Oct 30, 2016
Last update
Oct 16, 2017
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 Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310307
Lead sponsor
Al-Balqa Applied University
Collaborators
Jordan University of Science and Technology
Responsible party
Nahla Bayyari (Assistant Professor, Al-Balqa Applied University) — Principal investigator
First posted
Oct 16, 2017
Start date
Apr 1, 2016
Primary completion
Aug 30, 2016
Completion
Oct 30, 2016
Last update
Oct 16, 2017

Study contacts

Jehan M Hamadneh, FRCOG
principal investigator · JUST
Nahla S Al-Bayyari, PhD
study chair · BAU

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 Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Vitamin D

Start the discussion