NCT02297568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 23, 2020

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

November 10, 2014

Last Update Submit

October 21, 2020

Conditions

Deficiency, Vitamin D

Keywords

Breast-fed infantvitamin D supplementationLactation

Outcome Measures

Primary Outcomes (1)

  • Comparison serum 25OHD levels from breastfed infants

    6 weeks after delivery

Study Arms (2)

Calciferol,1800 IU/d supplement

ACTIVE COMPARATOR

The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to 1,800 IU/d .

Drug: Calciferol

Placebo

PLACEBO COMPARATOR

The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to receive placebo.

Drug: placebo

Interventions

CalciferolDRUG

Comparison 25OHD levels between calciferol and placebo

Also known as: Vitamin D3
Calciferol,1800 IU/d supplement
placeboDRUG
Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Feeding

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sathit Niramitmahapanya, MD

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 21, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 23, 2020

Record last verified: 2015-07

Locations

TH(1)