A randomized controlled clinical trial to compare the efficacy of Vitamin D vs placebo to reduce high blood sugar during pregnancy

A Randomized Control Trial comparing vitamin D supplementation versus placebo on glycemic control in gestational diabetes mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/020

Enrollment

Unknown

Registered

2018-06-25

Start date

2017-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes

Interventions

Study site is the antenatal clinic of the Colombo North Teaching Hospital, Ragama. Block randomization will be done using a computer generated sequence using a web based application. Block size has b

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women 2. Aged 18-40 years 3. Diagnosed as a Gestational diabetes by 75g Oral Glucose tolerance test 4. On medical nutritional therapy and/or metformin.

Exclusion criteria

Exclusion criteria: 1. Premature pre-labour rupture of membrane 2. Existing liver or kidney disease 3. Placental abruption 4. Pregnancy induced hypertension or Pre eclampsia 5. Diagnosed with Type 2 diabetes mellitus 6. Need insulin therapy during the intervention or already on insulin therapy 7. Smoking 8. Diagnosed with hypothyroidism 9. Diagnosed with calcium or vitamin D metabolism disorders 10. Already on Vitamin D supplementation

Design outcomes

Primary

Measure	Time frame
The mean difference of blood glucose levels in the two arms before and after the intervention. Blood glucose levels will be measured by fasting blood sugar (FBS) test and 1hour post prandial blood sugar (PPBS) (post breakfast) test [Day1 (before the intervention) and after 4 weeks of intervention.]	—

Secondary

Measure	Time frame
1. Occurrence of adverse drug effects such as craniofacial abnormalities, and dental abnormalities in infants. 2. Any other allergic reactions to the vitamin D treatment. 3. Side effects to participant due to excessive vitamin D intake such as, • Kidney stones • Confusion or disorientation • Muscle weakness • Bone pain • Poor appetite • Extreme thirst • Nausea, vomiting, or constipation. 4. Reduction in incidence of the following within the first 24 hours from delivery 5. Admissions to Premature Babies Unit (PBU) after delivery 6. Macrosomia 7. Polyhydramnios 8. Shoulder dystocia 9. Neonatal hypoglycemia Any difference of occurrence of the following 10. Gestational hypertension during the pregnancy 11. Caesarian section rate 12. Instrumental delivery rates [1. Adverse effects to Vitamin D in participant will be monitored during the trial period and until the delivery. 2. Occurrence of mentioned adverse drug effects in neonate will be observed within the first 24 hours of the delivery. ]	—

Measure

Time frame

1. Occurrence of adverse drug effects such as craniofacial abnormalities, and dental abnormalities in infants. 2. Any other allergic reactions to the vitamin D treatment. 3. Side effects to participant due to excessive vitamin D intake such as, • Kidney stones • Confusion or disorientation • Muscle weakness • Bone pain • Poor appetite • Extreme thirst • Nausea, vomiting, or constipation. 4. Reduction in incidence of the following within the first 24 hours from delivery 5. Admissions to Premature Babies Unit (PBU) after delivery 6. Macrosomia 7. Polyhydramnios 8. Shoulder dystocia 9. Neonatal hypoglycemia Any difference of occurrence of the following 10. Gestational hypertension during the pregnancy 11. Caesarian section rate 12. Instrumental delivery rates [1. Adverse effects to Vitamin D in participant will be monitored during the trial period and until the delivery. 2. Occurrence of mentioned adverse drug effects in neonate will be observed within the first 24 hours of the delivery. ]

—

Countries

Sri Lanka

Contacts

Public ContactDr. Tharaka Sandaruwan

Registrar

tarakasanda@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026