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
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.
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.
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 →RCSI & UCD Malaysia Campus is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vitamin D3 at 4000 iu per day for 6 months
Dietary Supplement: Vitamin D3
matching placebo- capsules containing soya oil at 4 capsules a day for 6 months
Dietary Supplement: Placebo
Change in glucose metabolism as assessed by change in Insulin sensitivity index as calculated by HOMA -IR28
Time frame: 6 months
Change in Insulin Sensitivity index as calculated by Oral Glucose Insulin Sensitivity Index (OGIS)
Time frame: 6 months
Change in plasma 25-OH- Vitamin D level pre and post replacement
Time frame: 6 months
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.
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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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Studies of the drug tested here: Cholecalciferol
RCSI & UCD Malaysia Campus