Diabetes Mellitus, GestationalNCT06896669
Effects of Vitamin D and Calcium on Hyperglycemia and Dyslipidemia in Patients Gestational Diabetes
A study testing vitamin D3 in people with Diabetes Mellitus, Gestational, run by Riphah International University at 1 site in Pakistan.
Trial summary
Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diabetes Mellitus, Gestational
- What is being tested?
- vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jan 2025to 5 Mar 2026
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-40 years.
- Gestational age between 24-28 weeks.
- Diagnosis of GDM based on OGTT results.
- Willingness of participants to provide written informed consent.
Who cannot join
- Pre-existing diabetes mellitus (type 1 or type 2).
- Chronic kidney or liver disease.
- Use of vitamin D or calcium supplements in the last 3 months.
- Multiple pregnancies (twins, triplets).
- Any major pregnancy complications (e.g., preeclampsia).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Synergistic Effects of Vitamin D and Calcium Supplementation on Hyperglycemia and Dyslipidemia in Patients With Gestational Diabetes
Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Another complication of GDM is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. The previous literature review indicates that micronutrients including vitamin D and calcium have a bearing on glucose and lipid profiles. Various studies have established that vitamin D improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. Furthermore, it is revealed that calcium induces vitamin D so that it could undergo its full metabolic effect. Hence, the addition of vitamin D and calcium together may enhance glycemic management and lipid profiles of GDM patients. The aim of the present work is to compare the impact of vitamin D and calcium supplementation on lipid profiles and hyperglycemia in GDM patients. It will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (HbA1c) and lipid profile (LDL, HDL triglycerides) and review the effect of this on pregnancy outcomes. These outcomes will be assessed by a randomized-controlled trial.
Read the detailed description
A randomized controlled trial study design will be used to assess the efficacy of vitamin D and calcium supplementation in lipid profiles and glycemic index among women with GDM.
The sample for the study will consist of 60 pregnant women diagnosed with GDM, aged 18-40 years, and between 24-28 weeks of gestation. Recruitment of participants will be done in antenatal clinics linked to [Lady Willingdon Hospital Lahore]. The diagnosis of GDM will be performed according to the results of OGTT following the international criteria.
Participants will be randomly divided to one of two groups:
- Intervention Group: This group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks.
- Control Group: This group will receive a placebo containing no active ingredients.
For randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. The study will be conducted as double blind; the participants and the researchers shall not know the group allocations.
- Conditions
- Diabetes Mellitus, Gestational
- Being tested
- vitamin D3
- Keywords
- Hyperglycemia, Lipid profiles, Pregnancy outcomes
- Medical subject headings
- Diabetes, Gestational, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Also called calcium
600IU of vitamin D3 and 1.5g of calcium will be provided for time period of 6 weeks once daily. In addition, Participants dietary intake will be assessed through 24 hours dietary recall.
| Study group | Role | What they receive |
|---|---|---|
| Arm and Interventions | Other | Experimental: Vitamin D3 and calcium This group will be receive vitamin D3 600 IU and 1.5 g of calcium. This treatment will be conducted for 6 week per day after meal. Receives: Dietary Supplement: vitamin D3 |
| Arm and placebo | Other | : This group will receive a placebo containing no active ingredients and it will conducted for 6 weeks per day. Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG) levels
fasting plasma glucose measures your blood sugar level post meal after at least 8 hours
Measured: 6 weeks
HbA1C
HbA1C measure glucose level in past 2 to 3 months
Measured: 6 weeks
Secondary outcomes (1)
lipid profile
Lipid profile, including total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides (TG).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start28 Jan 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, GestationalStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- It will be randomized control trial, in which intervention group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks and control group will receive a placebo containing no active ingredients.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faryal Gohar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896669
- Sponsor's protocol ID
- REC/RCR&AHS/24/0848
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2025
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Vitamin D and Calcium Supplementation on Hyperglycemia and Dyslipidemia in Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06896669
- Acronym / sponsor ID
- REC/RCR&AHS/24/0848
- Conditions
- Diabetes Mellitus, Gestational
- Keywords
- Hyperglycemia, Lipid profiles, Pregnancy outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 26 Mar 2025 (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.
Gestational diabetes mellitus (GDM) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. It has been linked to preeclampsia, C-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. Another complication of GDM is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. The previous literature review indicates that micronutrients including vitamin D and calcium have a bearing on glucose and lipid profiles. Various studies have established that vitamin D improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. Furthermore, it is revealed that calcium induces vitamin D so that it could undergo its full metabolic effect. Hence, the addition of vitamin D and calcium together may enhance glycemic management and lipid profiles of GDM patients. The aim of the present work is to compare the impact of vitamin D and calcium supplementation on lipid profiles and hyperglycemia in GDM patients. It will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (HbA1c) and lipid profile (LDL, HDL triglycerides) and review the effect of this on pregnancy outcomes. These outcomes will be assessed by a randomized-controlled trial.
Detailed description
A randomized controlled trial study design will be used to assess the efficacy of vitamin D and calcium supplementation in lipid profiles and glycemic index among women with GDM.
The sample for the study will consist of 60 pregnant women diagnosed with GDM, aged 18-40 years, and between 24-28 weeks of gestation. Recruitment of participants will be done in antenatal clinics linked to [Lady Willingdon Hospital Lahore]. The diagnosis of GDM will be performed according to the results of OGTT following the international criteria.
Participants will be randomly divided to one of two groups:
- Intervention Group: This group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks.
- Control Group: This group will receive a placebo containing no active ingredients.
For randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. The study will be conducted as double blind; the participants and the researchers shall not know the group allocations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized control trial, in which intervention group will receive 600 IU of vitamin D3 and 1.5-2 g of calcium daily for 6 weeks and control group will receive a placebo containing no active ingredients.
| Arm | Type | Receives |
|---|---|---|
| Arm and Interventions | Other | Dietary Supplement: vitamin D3Experimental: Vitamin D3 and calcium This group will be receive vitamin D3 600 IU and 1.5 g of calcium. This treatment will be conducted for 6 week per day after meal. |
| Arm and placebo | Other | Dietary Supplement: vitamin D3: This group will receive a placebo containing no active ingredients and it will conducted for 6 weeks per day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women aged 18-40 years.
- Gestational age between 24-28 weeks.
- Diagnosis of GDM based on OGTT results.
- Willingness of participants to provide written informed consent.
Key exclusion criteria (5 listed)
- Pre-existing diabetes mellitus (type 1 or type 2).
- Chronic kidney or liver disease.
- Use of vitamin D or calcium supplements in the last 3 months.
- Multiple pregnancies (twins, triplets).
- Any major pregnancy complications (e.g., preeclampsia).
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 |
|---|---|---|
| vitamin D3Also: calcium600IU of vitamin D3 and 1.5g of calcium will be provided for time period of 6 weeks once daily. In addition, Participants dietary intake will be assessed through 24 hours dietary recall. | Dietary supplement | Arm and Interventions, Arm and placebo |
Primary outcome
Fasting plasma glucose (FPG) levels
Time frame: 6 weeks
fasting plasma glucose measures your blood sugar level post meal after at least 8 hours
HbA1C
Time frame: 6 weeks
HbA1C measure glucose level in past 2 to 3 months
1 secondary outcome
lipid profile
Time frame: 6 weeks
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 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Gestational
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
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.
Faryal Gohar, MS 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 D3 in people with Diabetes Mellitus, Gestational, run by Riphah International University 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 4 inclusion and 5 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 17 Mar 2026. 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. 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?
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?
Fasting plasma glucose (FPG) levels (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 17 Mar 2026.