Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

NCT ID: NCT01419743

Last Updated: 2014-02-19

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-01-31

Brief Summary

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Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

Detailed Description

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The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

Conditions

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Infertility Vitamin D Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles

Exclusion Criteria

* Infertile women aged \> 38 undergoing fresh invitro fertilization cycles
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Irene Moy

Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 19589516 (View on PubMed)

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

Reference Type BACKGROUND
PMID: 17634462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20832734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18525006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12163674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10746634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7400847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12609940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17389701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18574092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17535985 (View on PubMed)

Other Identifiers

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Moy 2011 Vit D

Identifier Type: -

Identifier Source: org_study_id

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