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CompletedNCT01992133Updated Nov 25, 2013

Effects of Vitamin D Supplementation on Glucose Metabolism in Women With Former Gestational Diabetes Mellitus

An interventional study of Vitamin D3 and Placebo in Gestational Diabetes Mellitus in Pregnancy and Vitamin D Deficiency, sponsored by RCSI & UCD Malaysia Campus. Completed at 1 site in Malaysia. Open to female participants. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by RCSI & UCD Malaysia Campus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Sex
Female
01

Study 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.

Read the detailed description

Gestational diabetes mellitus (GDM) is a state of glucose intolerance occurring during pregnancy and is related to both resistance to peripheral action of insulin and impairment of beta (β)-cell function. Its transient presence during pregnancy alerts to a heightened risk of diabetes in the future. About 10-50% of women with GDM develop diabetes mellitus later on in life. Data from Malaysia found that 50% of GDM women had developed diabetes at an interval of five to seven years post index pregnancy. Therefore, it is paramount that the investigators identify effective measures to prevent diabetes progression in this high-risk group.

Vitamin D deficiency has been shown to be associated with insulin resistance and impaired pancreatic function. Vitamin D deficiency is more prevalent in women with GDM and low vitamin D levels correlate with insulin resistance.

Interventional studies using vitamin D supplement in an attempt to modify glucose metabolism have yielded mixed results. This may be partly due to variable doses of supplementation used, short duration of follow up and inappropriate target group. A very short duration of less than seven days of supplementation may not be sufficient to demonstrate the potential beneficial effects. Previous studies suggested vitamin D replacement improved glucose metabolism in selected populations only. Benefit was seen in subjects with impaired fasting glucose but not in normal volunteers, nor in patients with established chronic diabetes. It is possible that vitamin D can help with early stage of disturbance in glucose handling, but is unable to augment insulin secretion in subjects with chronic diabetes and exhausted pancreatic function. Lack of adequate dosing may have also accounted for the failure of many previous studies to demonstrate beneficial effects of vitamin D replacement. Adequate vitamin D supplementation would ideally raise blood 25-hydroxyvitamin D (25(OH)D) levels above 80nmol/L because diabetes risk is lowest at this vitamin D level. Supplementation with 4000IU of vitamin D3 per day in a population of South Asian women with proven vitamin D deficiency safely restored the vitamin D level and improved insulin resistance.

Very little is known about the relationship between vitamin D status and glucose metabolism in women with former GDM. This study aimed to evaluate the effect of adequate vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of cardio-metabolic risk in Malaysian women with former GDM and vitamin D insufficiency.

02

Conditions studied

  • Gestational Diabetes Mellitus in Pregnancy
  • Vitamin D Deficiency

Keywords

  • Former gestational Diabetes
  • Vitamin D deficiency
  • insulin resistance
  • beta cell function
03

In context

Vitamin D Deficiency

784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 26 is below the median of 77 across 574 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

RCSI & UCD Malaysia Campus is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or Breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Vitamin D3

    Vitamin D3 at 4000 iu per day for 6 months

    Dietary Supplement: Vitamin D3

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin D3
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

07

Study locations

1 site
  • Penang Medical College
    George Town, 11450, Malaysia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2013
First posted
Nov 25, 2013
Start
Jun 2011
Primary completionActual
Aug 2012
CompletionActual
Aug 2012
Last update
Nov 25, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01992133
Lead sponsor
RCSI & UCD Malaysia Campus
Responsible party
Toh-Peng Yeow (Assoc Professor of Medicine, RCSI & UCD Malaysia Campus) — Principal investigator
First posted
Nov 25, 2013
Start date
Jun 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Nov 25, 2013

Study contacts

Toh Peng Yeow, MB BCH BAO, FRCP(Edin)
principal investigator · Penang Medical College, 4 Jalan Sepoy Lines, 11450, Penang, Malaysia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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