NCT01992133

Brief Summary

Gestational Diabetes Mellitus (GDM) and vitamin D deficiency are related to insulin resistance and impaired beta-cell function, with heightened risk for future development of diabetes. The investigators hypothesize that vitamin D supplementation to women with previous gestational diabetes may improve glucose metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

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

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

November 12, 2013

Last Update Submit

November 18, 2013

Conditions

Gestational Diabetes Mellitus in PregnancyVitamin D Deficiency

Keywords

Former gestational DiabetesVitamin D deficiencyinsulin resistancebeta cell function

Outcome Measures

Primary Outcomes (1)

  • Change in glucose metabolism as assessed by change in Insulin sensitivity index as calculated by HOMA -IR28

    6 months

Secondary Outcomes (2)

  • Change in Insulin Sensitivity index as calculated by Oral Glucose Insulin Sensitivity Index (OGIS)

    6 months

  • Change in plasma 25-OH- Vitamin D level pre and post replacement

    6 months

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 at 4000 iu per day for 6 months

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

matching placebo- capsules containing soya oil at 4 capsules a day for 6 months

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT
Vitamin D3
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • Women with Gestational Diabetes (GDM) on the most recent pregnancy- between 6 and 48 months post partum at time of recruitment to study
  • Previous GDM defined as-Fasting plasma glucose ≥ 7.0 mmol/l or 2-h plasma glucose ≥ 7.8 mmol/l on 75g OGTT performed during gestation OR As determined by treating physician during index pregnancy
  • With no plan to conceive again within the 6 months of study duration
  • With 75g OGTT at study baseline confirming either Normal respond, Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
  • Vitamin D deficiency at baseline - defined as Plasma 25-(OH) D concentration of between 15 and 50nmol/L

You may not qualify if:

  • Pregnancy or Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penang Medical College

George Town, 11450, Malaysia

Location

MeSH Terms

Conditions

Vitamin D DeficiencyInsulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Toh Peng Yeow, MB BCH BAO, FRCP(Edin)

    Penang Medical College, 4 Jalan Sepoy Lines, 11450, Penang, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Professor of Medicine

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 25, 2013

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

MY(1)