Overweight and ObesityNCT04841265
The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
A study testing Vitamin D3 in people with Overweight and Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteSingapore
- Study dates
- 28 May 2021to 31 Mar 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestation ≤16weeks (16 weeks + 6 days) upon intervention
- Pre-pregnancy BMI ≥25 kg/m2
- Aged 21-45 years
- Willing and able to provide written, informed consent
Who cannot join
- Having current or past hypo/hyperparathyroidism, hypercalciuria, hypercalcemia or osteomalacia
- History of renal disease (including kidney stones and etc.), liver dysfunction, tuberculosis or sarcoidosis
- Pre-existing diabetes mellitus or chronic hypertension
- Taking lipid-lowering medicine
- Gestational diabetes (as confirmed by oral glucose tolerance test) or gestational hypertensive disorder
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
Read the detailed description
The effects of vitamin D supplementation on pregnancy outcomes and metabolic status of overweight and obese pregnant women remain uncertain. In particular, the dosage of vitamin D supplementation has not been defined in this high risk group of women. This study aims to examine whether oral supplement of vitamin D3 (cholecalciferol) in total dosage of 800 IU(prenatal multivitamin containing 400 IU vitamin D3 + 400 IU vitamin D3 alone) given to overweight and obese pregnant women since early pregnancy until delivery can improve maternal and neonatal outcomes, compared with those given prenatal multivitamin containing 400 IU vitamin D3 supplementation, a commonly given antenatal supplement in Singapore. The investigators' hypothesis is that higher dose vitamin D supplementation would lead to better outcomes in overweight and obese pregnant women. The investigators will conduct a two-arm, parallel non-blinded randomized controlled trial. Women with body mass index ≥25kg/m2 will be randomly assigned into groups with a 1:1 randomization ratio, receiving either 800 or 400 IU vitamin D3 supplementation. The study will be conducted at the antenatal clinics, KK Women's and Children's Hospital, Singapore. Measurements of serum 25-hydroxyvitamin D (25OHD), lipid profile and lifestyles information will be taken for all women at baseline (≤16 weeks gestation) and after three months of intervention (26-30 weeks gestation). All women will continue with the vitamin D3 supplementation until delivery. Primary outcomes include levels of maternal serum 25OHDconcentration and lipid profile at 26-30 gestation weeks as compared with the controls, adjusting for baseline measurements. Secondary outcomes include preeclampsia, gestational hypertension, gestational diabetes, glycaemic levels, caesarean section, gestational weight gain, preterm birth, low birth weight and small-for-gestational-age. This study will fill up the gap of knowledge regarding the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
- Conditions
- Overweight and Obesity
- Being tested
- Vitamin D3
- Keywords
- Vitamin D supplementation, Lipid profile, Vitamin D status, Birth outcomes, Pregnancy complications
- Medical subject headings
- Overweight, Obesity, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | The Vitamin D3 (intervention) arm will receive a total of 800 IU vitamin D3 supplementation per day. Receives: Dietary Supplement: Vitamin D3 |
| Control | No intervention | The control arm will receive 400 IU vitamin D3 per day from routine antenatal multivitamin supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maternal serum 25OHD concentration
Measured: Baseline, 26-30 gestational weeks
Change in maternal total cholesterol level
Measured: Baseline, 26-30 gestational weeks
Change in maternal HDL-cholesterol level
Measured: Baseline, 26-30 gestational weeks
Change in maternal LDL-cholesterol level
Measured: Baseline, 26-30 gestational weeks
Change in maternal triglyceride level
Measured: Baseline, 26-30 gestational weeks
Secondary outcomes (13)
Incidence of preeclampsia
Measured: up to delivery
Incidence of gestational hypertension
Measured: Through pregnancy until delivery
Incidence of gestational diabetes
Measured: Through pregnancy until delivery
Fasting glucose level
Measured: 24-28 gestational weeks
1-hour post-load glucose level
Measured: 24-28 gestational weeks
2-hour post-load glucose level
Measured: 24-28 gestational weeks
Incidence of caesarean section
Measured: At delivery
Incidence of preterm birth (<37 weeks)
Measured: At delivery
Incidence of low birth weight (<2500g)
Measured: At delivery
Neonatal birth weight (g)
Measured: At delivery
Neonatal birth length (cm)
Measured: At delivery
Neonatal head circumference (cm)
Measured: At delivery
Incidence of admission to special care (including intensive care) during neonatal period
Measured: Within 28 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start28 May 2021
- Primary completion11 Apr 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Loy See Ling, KK Women's and Children's Hospital
- Investigators
- Dr Loy See Ling, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841265
- Sponsor's protocol ID
- CIRB 2021/2055
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2021
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT04841265
- Acronym / sponsor ID
- CIRB 2021/2055
- Conditions
- Overweight and Obesity
- Keywords
- Vitamin D supplementation, Lipid profile, Vitamin D status, Birth outcomes, Pregnancy complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 28 May 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 Apr 2021 (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.
To understand the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
Detailed description
The effects of vitamin D supplementation on pregnancy outcomes and metabolic status of overweight and obese pregnant women remain uncertain. In particular, the dosage of vitamin D supplementation has not been defined in this high risk group of women. This study aims to examine whether oral supplement of vitamin D3 (cholecalciferol) in total dosage of 800 IU(prenatal multivitamin containing 400 IU vitamin D3 + 400 IU vitamin D3 alone) given to overweight and obese pregnant women since early pregnancy until delivery can improve maternal and neonatal outcomes, compared with those given prenatal multivitamin containing 400 IU vitamin D3 supplementation, a commonly given antenatal supplement in Singapore. The investigators' hypothesis is that higher dose vitamin D supplementation would lead to better outcomes in overweight and obese pregnant women. The investigators will conduct a two-arm, parallel non-blinded randomized controlled trial. Women with body mass index ≥25kg/m2 will be randomly assigned into groups with a 1:1 randomization ratio, receiving either 800 or 400 IU vitamin D3 supplementation. The study will be conducted at the antenatal clinics, KK Women's and Children's Hospital, Singapore. Measurements of serum 25-hydroxyvitamin D (25OHD), lipid profile and lifestyles information will be taken for all women at baseline (≤16 weeks gestation) and after three months of intervention (26-30 weeks gestation). All women will continue with the vitamin D3 supplementation until delivery. Primary outcomes include levels of maternal serum 25OHDconcentration and lipid profile at 26-30 gestation weeks as compared with the controls, adjusting for baseline measurements. Secondary outcomes include preeclampsia, gestational hypertension, gestational diabetes, glycaemic levels, caesarean section, gestational weight gain, preterm birth, low birth weight and small-for-gestational-age. This study will fill up the gap of knowledge regarding the role of vitamin D supplementation on pregnancy outcomes and metabolic status in overweight and obese pregnant women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3The Vitamin D3 (intervention) arm will receive a total of 800 IU vitamin D3 supplementation per day. |
| Control | No intervention | –The control arm will receive 400 IU vitamin D3 per day from routine antenatal multivitamin supplementation. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestation ≤16weeks (16 weeks + 6 days) upon intervention
- Pre-pregnancy BMI ≥25 kg/m2
- Aged 21-45 years
- Willing and able to provide written, informed consent
Key exclusion criteria (6 listed)
- Having current or past hypo/hyperparathyroidism, hypercalciuria, hypercalcemia or osteomalacia
- History of renal disease (including kidney stones and etc.), liver dysfunction, tuberculosis or sarcoidosis
- Pre-existing diabetes mellitus or chronic hypertension
- Taking lipid-lowering medicine
- Gestational diabetes (as confirmed by oral glucose tolerance test) or gestational hypertensive disorder
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 D3The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery. | Dietary supplement | Vitamin D3 |
Primary outcome
Change in maternal serum 25OHD concentration
Time frame: Baseline, 26-30 gestational weeks
Change in maternal total cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal HDL-cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal LDL-cholesterol level
Time frame: Baseline, 26-30 gestational weeks
Change in maternal triglyceride level
Time frame: Baseline, 26-30 gestational weeks
13 secondary outcomes
Incidence of preeclampsia
Time frame: up to delivery
Incidence of gestational hypertension
Time frame: Through pregnancy until delivery
Incidence of gestational diabetes
Time frame: Through pregnancy until delivery
Fasting glucose level
Time frame: 24-28 gestational weeks
1-hour post-load glucose level
Time frame: 24-28 gestational weeks
2-hour post-load glucose level
Time frame: 24-28 gestational weeks
Incidence of caesarean section
Time frame: At delivery
Incidence of preterm birth (<37 weeks)
Time frame: At delivery
Incidence of low birth weight (<2500g)
Time frame: At delivery
Neonatal birth weight (g)
Time frame: At delivery
Neonatal birth length (cm)
Time frame: At delivery
Neonatal head circumference (cm)
Time frame: At delivery
Incidence of admission to special care (including intensive care) during neonatal period
Time frame: Within 28 days after delivery
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 8 Jul 2024.
- 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.
Dr Loy See Ling, PhD principal investigator
KK Women's and Children's Hospital
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 Overweight and Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 6 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 8 Jul 2024. 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 Singapore. 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?
Change in maternal serum 25OHD concentration (time frame: Baseline, 26-30 gestational weeks). The study lists 5 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 8 Jul 2024.