Gestational Diabetes MellitusNCT06139133
The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM
A study testing Vitamin D supplementation in people with Gestational Diabetes Mellitus, run by IIMC, Riphah International University, Pakistan at 1 site in Pakistan.
Trial summary
A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Vitamin D supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2024to Dec 2025
- Phase
- Interventional
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with 07-11 weeks of gestation
- 21 - 40 Years age range
- Pregnant women with high risk for GDM
- history of GDM in their previous pregnancy,
- one or more first-degree relative diagnosed with diabetes mellitus,
- overweight-BMI >25 kg/m2 or obese-BMI >30 kg/m2 at their first antenatal visit
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- with a history of polycystic ovarian syndrome.
- Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT
- Low levels of Vitamin D3 (<30ng/ml)
Who cannot join
- Women already diagnosed with diabetes mellitus
- Any other systemic disease.
- High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT
- High risk pregnant women with normal vitamin D3 levels (>30ng/ml).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway Hospital
Rawalpindi, Punjab Province, 46000
Prof. Saaadia Sultana, FCPS, +923005051033, saadia.sultana@riphah.edu.pk
Shazia Qayyum, PhD
About this study
Official title: The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.
A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.
Read the detailed description
Gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. Studies have suggested a potential role of vitamin D status in GDM risk, but evidence from randomized controlled trials is inadequate and inconclusive. A research has been planned to investigate the effect of vitamin D supplementation on GDM development among high risk pregnant women through a well-designed RCT Pregnant women at a risk to develop GDM with low vitamin D levels (<30 ng/mL) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or placebo. Randomization will be achieved using a computer-generated random sequence or a randomization table. The allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin D and placebo groups. The primary outcome will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria after 75 g OGTT.
This study will contribute to the understanding of the relationship between vitamin D and GDM risk through a well-designed RCT with integrated approaches. The findings may inform clinical practice and public health recommendations for vitamin D supplementation during pregnancy.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Placebo supplementation, Vitamin D supplementation
- Keywords
- Gestational Diabetes Mellitus, Pregnancy, High risk women, Vitamin D supplementation
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementationDrug
Placebo
Vitamin D supplementationDrug
Vitamin D3 supplementation (2 00,000 IU/Week)
| Study group | Role | What they receive |
|---|---|---|
| Placebo supplementation Group | Placebo comparator | Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (<30ng/ml) will be included. The study subjects will be randomly assigned to receive placebo until delivery. Receives: Drug: Placebo supplementation |
| Vitamin D supplementation group | Experimental | pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (<30ng/ml) will be included for Vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 week. The study subjects will be randomly assigned to receive vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks. Receives: Drug: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes mellitus with 75g OGTT
75g-OGTT is an oral glucose tolerance test done by ingesting 75 g glucose dissolved in water in the morning at 7- 8 am.
- Patient seated quietly \& relaxed for 30 mins before taking the test
- A zero-time (baseline) blood sample is drawn
- The patient is then given a 75-g glucose solution to drink within 5 minutes
- 2nd Sample - 1h after consumption of sugar to measure the blood glucose
- 3rd Sample- 2h after consumption of sugar to measure blood glucose
- Both blood samples should be kept in fluoride-containing collection tubes
Interpretation of Test:
GDM diagnosed if any one of the following is present after 75g OGTT:
- FPG: >92 mg/dl
- 1-hour PG: >180 mg/dl
- 2-hour PG: >153 mg/dl
- THE WHO GUIDELINES (2018)
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IIMC, Riphah International University, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Nadim Akbar Khan, FCPS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139133
- Sponsor's protocol ID
- Riphah/IIMC/IRC/23/3073
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D Supplementation on Gestational Diabetes Mellitus Risk in Pakistani Females: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06139133
- Acronym / sponsor ID
- Riphah/IIMC/IRC/23/3073
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes Mellitus, Pregnancy, High risk women, Vitamin D supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- IIMC, Riphah International University, PakistanUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.
Detailed description
Gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. Studies have suggested a potential role of vitamin D status in GDM risk, but evidence from randomized controlled trials is inadequate and inconclusive. A research has been planned to investigate the effect of vitamin D supplementation on GDM development among high risk pregnant women through a well-designed RCT Pregnant women at a risk to develop GDM with low vitamin D levels (<30 ng/mL) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or placebo. Randomization will be achieved using a computer-generated random sequence or a randomization table. The allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin D and placebo groups. The primary outcome will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria after 75 g OGTT.
This study will contribute to the understanding of the relationship between vitamin D and GDM risk through a well-designed RCT with integrated approaches. The findings may inform clinical practice and public health recommendations for vitamin D supplementation during pregnancy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Placebo supplementation Group | Placebo comparator | Drug: Placebo supplementationPregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (<30ng/ml) will be included. The study subjects will be randomly assigned to receive placebo until delivery. |
| Vitamin D supplementation group | Experimental | Drug: Vitamin D supplementationpregnant women with 07-11 weeks of gestation having normal response to 75g OGTT but with low levels of Vitamin D3 (<30ng/ml) will be included for Vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 week. The study subjects will be randomly assigned to receive vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Pregnant women with 07-11 weeks of gestation
- 21 - 40 Years age range
- Pregnant women with high risk for GDM
- history of GDM in their previous pregnancy,
- one or more first-degree relative diagnosed with diabetes mellitus,
Key exclusion criteria (4 listed)
- Women already diagnosed with diabetes mellitus
- Any other systemic disease.
- High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT
- High risk pregnant women with normal vitamin D3 levels (>30ng/ml).
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 |
|---|---|---|
| Placebo supplementationPlacebo | Drug | Placebo supplementation Group |
| Vitamin D supplementationVitamin D3 supplementation (2 00,000 IU/Week) | Drug | Vitamin D supplementation group |
Primary outcome
Gestational diabetes mellitus with 75g OGTT
Time frame: 28 weeks
75g-OGTT is an oral glucose tolerance test done by ingesting 75 g glucose dissolved in water in the morning at 7- 8 am. * Patient seated quietly \& relaxed for 30 mins before taking the test * A zero-time (baseline) blood sample is drawn * The patient is then given a 75-g glucose solution to drink within 5 minutes * 2nd Sample - 1h after consumption of sugar to measure the blood glucose * 3rd Sample- 2h after consumption of sugar to measure blood glucose * Both blood samples should be kept in fluoride-containing collection tubes Interpretation of Test: GDM diagnosed if any one of the following is present after 75g OGTT: * FPG: >92 mg/dl * 1-hour PG: >180 mg/dl * 2-hour PG: >153 mg/dl * THE WHO GUIDELINES (2018)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Muhammad Nadim Akbar Khan, FCPS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in people with Gestational Diabetes Mellitus, run by IIMC, Riphah International University, Pakistan at 1 site in Pakistan.
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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nadim Akbar Khan, FCPS (+923005190704, nadeem.akbar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes mellitus with 75g OGTT (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.