HomocystinaemiaPhase 2NCT03310307
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
A Phase 2 study testing Vit D in people with Homocystinaemia and Vitamin D Deficiency, run by Al-Balqa Applied University at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Homocystinaemia, Vitamin D Deficiency
- What is being tested?
- Vit D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2016to 30 Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (BMI 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
Who cannot join
- age < 18 or > 49 years
- BMI > 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail
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.
- Conditions
- Homocystinaemia, Vitamin D Deficiency
- Being tested
- Vit D, Placebo
- Keywords
- Homocysteine, Overweight, vitamin D3, Reproductive women, RCT
- Medical subject headings
- Vitamin D Deficiency, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDrug
Also called Biodal
50,000 IU
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3 | Active comparator | 50,000 IU Receives: Drug: Vit D |
| Placebo | Placebo comparator | Similar in size, shape and color to vitamin D3 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D3
vitamin D in serum
Measured: 2 months
Secondary outcomes (1)
Homocysteine
serum total homocysteine
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Apr 2016
- Primary completion30 Aug 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HomocystinaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Balqa Applied University
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Nahla Bayyari, Al-Balqa Applied University
- Investigators
- Jehan M Hamadneh, FRCOG, Principal investigator, JUSTNahla S Al-Bayyari, PhD, Study chair, BAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310307
- Sponsor's protocol ID
- Hcy-VitD-01
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT03310307
- Acronym / sponsor ID
- Hcy-VitD-01
- Conditions
- Homocystinaemia, Vitamin D Deficiency
- Keywords
- Homocysteine, Overweight, vitamin D3, Reproductive women, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Balqa Applied UniversityUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3 | Active comparator | Drug: Vit D50,000 IU |
| Placebo | Placebo comparator | Other: PlaceboSimilar in size, shape and color to vitamin D3 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Overweight (BMI 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
Key exclusion criteria (7 listed)
- age < 18 or > 49 years
- BMI > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit DAlso: Biodal50,000 IU | Drug | vitamin D3 |
| Placebo | Other | Placebo |
Primary outcome
25(OH)D3
Time frame: 2 months
vitamin D in serum
1 secondary outcome
Homocysteine
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Derived from this study: PubMed 30442234Al-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jehan M Hamadneh, FRCOG principal investigator
JUST
Nahla S Al-Bayyari, PhD study chair
BAU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vit D in people with Homocystinaemia and Vitamin D Deficiency, run by Al-Balqa Applied University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25(OH)D3 (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.