Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
NCT ID: NCT01419743
Last Updated: 2014-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
102 participants
OBSERVATIONAL
2011-08-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with Vit D level of < 20ng/mL: Group 1
randomized to receive 400 IU of vitamin D per day
No interventions assigned to this group
patients with Vit D levels <20ng/mL: Group 2
Randomized to receive 2000IU of Vitamin D per day
No interventions assigned to this group
patients with vit D levels between 20-30 ng/mL: Group 3
Randomized to receiving placebo
No interventions assigned to this group
patients with vit D levels between 20-30 ng/mL: Group 4
Randomized to receive 400IU of vitamin D per day
No interventions assigned to this group
patients with vit D levels between 20-30 ng/mL: Group 5
Randomized to receive 2000IU of vitamin D per day
No interventions assigned to this group
patients with vit D levels > 30ng/mL: Group 6
No treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients undergoing frozen embryo transfers
* Patients undergoing donor-egg cycles
* Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)
18 Years
38 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Irene Moy
Clinical Fellow
Principal Investigators
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Ralph Kazer, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Faculty Foundation
Irene Moy, MD
Role: STUDY_CHAIR
Northwestern University
Locations
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Northwestern Memorial Faculty Foundation
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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References
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Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Barrett H, McElduff A. Vitamin D and pregnancy: An old problem revisited. Best Pract Res Clin Endocrinol Metab. 2010 Aug;24(4):527-39. doi: 10.1016/j.beem.2010.05.010.
Heaney RP. Vitamin D in health and disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1535-41. doi: 10.2215/CJN.01160308. Epub 2008 Jun 4.
Johnson LE, DeLuca HF. Reproductive defects are corrected in vitamin d-deficient female rats fed a high calcium, phosphorus and lactose diet. J Nutr. 2002 Aug;132(8):2270-3. doi: 10.1093/jn/132.8.2270.
Kinuta K, Tanaka H, Moriwake T, Aya K, Kato S, Seino Y. Vitamin D is an important factor in estrogen biosynthesis of both female and male gonads. Endocrinology. 2000 Apr;141(4):1317-24. doi: 10.1210/endo.141.4.7403.
Halloran BP, DeLuca HF. Effect of vitamin D deficiency on fertility and reproductive capacity in the female rat. J Nutr. 1980 Aug;110(8):1573-80. doi: 10.1093/jn/110.8.1573.
Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ. 2003 Mar 1;326(7387):469. doi: 10.1136/bmj.326.7387.469.
Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
Dobnig H, Pilz S, Scharnagl H, Renner W, Seelhorst U, Wellnitz B, Kinkeldei J, Boehm BO, Weihrauch G, Maerz W. Independent association of low serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality. Arch Intern Med. 2008 Jun 23;168(12):1340-9. doi: 10.1001/archinte.168.12.1340.
Bodnar LM, Catov JM, Simhan HN, Holick MF, Powers RW, Roberts JM. Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab. 2007 Sep;92(9):3517-22. doi: 10.1210/jc.2007-0718. Epub 2007 May 29.
Other Identifiers
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Moy 2011 Vit D
Identifier Type: -
Identifier Source: org_study_id
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