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Vitamin D Supplementation During Lactation

Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02297568
Enrollment
80
Registered
2014-11-21
Start date
2014-03-31
Completion date
2015-06-30
Last updated
2020-10-23

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

Conditions

Deficiency, Vitamin D

Keywords

Breast-fed infant, vitamin D supplementation, Lactation

Brief summary

This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.

Detailed description

Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.

Interventions

Comparison 25OHD levels between calciferol and placebo

DRUGplacebo

Sponsors

Queen Sirikit National Institute of Child Health
CollaboratorOTHER_GOV
Department of Medical Services Ministry of Public Health of Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Pregnant Thai women and intends to deliver at Rajavithi Hospital * Insufficient Vitamin D levels (25(OH)D \< 30ng/ml) * Gestational age at birth and no complications

Exclusion criteria

* Age \< 18 years old * Unintended to deliver at Rajavithi Hospital * Insufficient Vitamin D levels (25(OH)D \< 10ng/ml)

Design outcomes

Primary

MeasureTime frame
Comparison serum 25OHD levels from breastfed infants6 weeks after delivery

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026