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Optimal Dose of Vitamin D Supplement for Pregnant Women with Hypovitaminosis D: A Randomized Controlled Trial

Optimal Dose of Vitamin D Supplement for Pregnant Women with Hypovitaminosis D: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250614004
Enrollment
90
Registered
2025-06-14
Start date
2025-07-01
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

Hypovitaminosis D in pregnancy and associated maternal and neonatal complications such as pre-eclampsia, gestational diabetes, preterm birth, and low birth weight. Vitamin D Supplement Hypovitaminosis D Vitamin D insufficiency Vitamin D deficiency

Interventions

Vitamin D2 20,000 IU orally once monthly From gestational age 12 to 20 weeks until delivery,Vitamin D2 40,000 IU orally once monthly From gestational age 12 to 20 weeks until delivery,Vitamin D2 60,00
Experimental Drug,Experimental Drug,Experimental Drug
Vitamin D 20000 IU per month,Vitamin D 40000 IU per month,Vitamin D 60000 IU per month

Sponsors

Rajavithi hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1 Singleton pregnancy 2 Aged between 20 to 5 years 3 Gestational age between 12 to20 weeks, confirmed by ultrasound in the first or second trimester. 4 Low blood vitamin D levels (25(OH)D below 30 ng/mL) 5 Able to communicate and understand Thai well to comprehend research explanations and personally sign consent forms. 6 Willing to participate in the research

Exclusion criteria

Exclusion criteria: 1 Pre-existing diabetes (diabetes diagnosed before pregnancy) 2 History of gestational diabetes 3 Kidney disease, liver disease, or conditions affecting vitamin D metabolism such as 4 malabsorption syndromes or genetic disorders related to vitamin D metabolism. 5 Autoimmune diseases like SLE (Systemic Lupus Erythematosus) or Multiple Sclerosis. 6 Hyperparathyroidism or high blood calcium levels. 7 History of using vitamin D supplements prior to the study. 8 Unable to follow up for the second vitamin D level measurement. 9 Hypertension (high blood pressure). 10 History of pre-eclampsia. 11 History of taking calcium supplements containing vitamin D.

Design outcomes

Primary

MeasureTime frame
maternal serum 25(OH)D level during the third trimester ng/mL

Secondary

MeasureTime frame
Maternal outcomes during the third trimester GDM, preeclampsia, serum calcium/phosphate,Neonatal outcomes at delivery preterm birth, birth weight, Apgar score, cord blood vitamin D,Adverse effects from vitamin D supplementation during the third trimester any symptoms

Countries

Thailand

Contacts

Public ContactDennopporn Sudjai

Rajavithi hospital

dangobgyn@gmail.com0932565399

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026