Zahra Mirzaei-Azandaryani1, Sakineh Mohammad-Alizadeh-Charandabi2, Elnaz Shaseb3, Shamsi Abbasalizadeh4, Mojgan Mirghafourvand5. 1. Students' research committee, Nursing and Midwifery Faculty, Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. 3. Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. 4. Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Social Determinants of Health Research Center, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.
Abstract
BACKGROUND: Gestational diabetes is one of the most common metabolic disorders during pregnancy. Some studies have reported the effect of vitamin D deficiency on the incidence of this disorder. Therefore, the purpose of the present study was to determine the effect of vitamin D supplementation on fasting blood glucose (FBG) levels, fasting blood insulin (FBI) levels and insulin resistance index (HOMA-IR) (primary outcomes) and symptoms of depression, musculoskeletal pain, frequency of gestational diabetes and the frequency of abortion (secondary outcomes). METHODS: In this triple-blind randomized controlled trial, 88 pregnant women at 8-10 weeks of pregnancy who had the vitamin D of less than 30 ng/ml were randomly assigned to the vitamin D group (n = 44) and control group (n = 44) using block randomization. The vitamin D group received 4,000 units of vitamin D tablets daily and the control group received placebo tablets for 18 weeks. Independent t-test, Mann-Whitney U and ANCOVA tests were used to analyze the data. RESULTS: After the intervention, there was no statistically significant difference between the two groups in terms of FBG (P = 0.850), FBI (P = 0.353), HOMA-IR (P = 0.632), mean score of depressive symptoms (P = 0.505), frequency of gestational diabetes (P = 0.187) and frequency of abortion (P = 1.000) and there was only a difference in terms of serum vitamin D level (P = 0.016) and musculoskeletal pain including knee pain (P = 0.025), ankle pain (P < 0.001) and leg pain (P < 0.001). CONCLUSION: Vitamin D could improve the musculoskeletal pain in pregnant women but couldn't decrease FBG, FBI, HOMA-IR, depression symptoms score, incidence of GDM and abortion. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N59. Date of registration: 4/11/2020. URL: https://en.irct.ir/user/trial/50973/view ; Date of first registration: 21/11/2020.
BACKGROUND: Gestational diabetes is one of the most common metabolic disorders during pregnancy. Some studies have reported the effect of vitamin D deficiency on the incidence of this disorder. Therefore, the purpose of the present study was to determine the effect of vitamin D supplementation on fasting blood glucose (FBG) levels, fasting blood insulin (FBI) levels and insulin resistance index (HOMA-IR) (primary outcomes) and symptoms of depression, musculoskeletal pain, frequency of gestational diabetes and the frequency of abortion (secondary outcomes). METHODS: In this triple-blind randomized controlled trial, 88 pregnant women at 8-10 weeks of pregnancy who had the vitamin D of less than 30 ng/ml were randomly assigned to the vitamin D group (n = 44) and control group (n = 44) using block randomization. The vitamin D group received 4,000 units of vitamin D tablets daily and the control group received placebo tablets for 18 weeks. Independent t-test, Mann-Whitney U and ANCOVA tests were used to analyze the data. RESULTS: After the intervention, there was no statistically significant difference between the two groups in terms of FBG (P = 0.850), FBI (P = 0.353), HOMA-IR (P = 0.632), mean score of depressive symptoms (P = 0.505), frequency of gestational diabetes (P = 0.187) and frequency of abortion (P = 1.000) and there was only a difference in terms of serum vitamin D level (P = 0.016) and musculoskeletal pain including knee pain (P = 0.025), ankle pain (P < 0.001) and leg pain (P < 0.001). CONCLUSION: Vitamin D could improve the musculoskeletal pain in pregnant women but couldn't decrease FBG, FBI, HOMA-IR, depression symptoms score, incidence of GDM and abortion. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N59. Date of registration: 4/11/2020. URL: https://en.irct.ir/user/trial/50973/view ; Date of first registration: 21/11/2020.
Authors: Kaiser Wani; Shaun Sabico; Abdullah M Alnaami; Sara Al-Musharaf; Mona A Fouda; Iqbal Z Turkestani; Abdulrahman Al-Ajlan; Naemah M Alshingetti; Majed S Alokail; Nasser M Al-Daghri Journal: Front Endocrinol (Lausanne) Date: 2020-02-27 Impact factor: 5.555