Table of contents
Vitamin D3 supplementation during pregnancy and lactation for women living with HIV in Tanzania: A randomized controlled trial
PLoS Med. 2022 Apr 15;19(4):e1003973. doi: 10.1371/journal.pmed.1003973.
Christopher R Sudfeld 1 2, Karim P Manji 3, Alfa Muhihi 4, Christopher P Duggan 2 5, Said Aboud 6, Fadhlun M Alwy Al-Beity 7, Molin Wang 8 9 10, Ning Zhang 9, Nzovu Ulenga 4, Wafaie W Fawzi 1 2 9
Background: Observational studies suggest that vitamin D deficiency among people living with HIV is associated with a greater risk of disease progression and death. Low levels of vitamin D in pregnancy are also associated with poor fetal and infant growth. Therefore, vitamin D supplementation may improve clinical outcomes for pregnant women living with HIV and improve fetal and postnatal growth for their infants.
Methods and findings: We conducted a randomized, triple-blind, placebo-controlled trial of vitamin D3 supplementation among pregnant and lactating women living with HIV in Dar es Salaam, Tanzania (ClinicalTrials.gov NCT02305927). Participants were randomized with 1:1 allocation stratified by study clinic to receive either daily 3,000 IU vitamin D3 supplements or matching placebo supplements from the second trimester of pregnancy (12-27 weeks) until 1 year postpartum. The primary outcomes were (i) maternal HIV progression or death, (ii) small-for-gestational-age (SGA) live births (<10th percentile), and (iii) infant stunting at 1 year of age (length-for-age z-score < -2). We also examined the effect of vitamin D3 supplementation on secondary maternal and infant health outcomes, maternal and infant serum 25-hydroxyvitamin D (25OHD) concentrations, and maternal hypercalcemia. An intent-to-treat analysis was used as the primary analytic approach. We enrolled 2,300 pregnant women between June 15, 2015, and April 17, 2018, and follow-up of mothers and infants was completed on October 20, 2019. There were 1,148 pregnant women randomly assigned to the vitamin D3 group, and 1,152 to the placebo group. The proportion of mothers lost to follow-up at 1 year postpartum was 6.6% in the vitamin D3 group (83 of 1,148) and 6.6% in the placebo group (76 of 1,152). The proportion of children lost to follow-up at 1 year of age was 5.5% in the vitamin D3 group (59 of 1,074 live births) and 5.2% in the placebo group (57 of 1,093 live births). There was no difference in the risk of maternal HIV progression or death, with 166 events during 1,461 person-years of follow-up in the vitamin D3 group and 141 events during 1,469 person-years of follow-up in the placebo group (hazard ratio 1.21, 95% CI 0.97 to 1.52, p = 0.09). There was no difference in the risk of SGA birth between the vitamin D3 (229 SGA births among 1,070 live births) and placebo groups (236 SGA births among 1,091 live births) (relative risk 1.03, 95% CI 0.87 to 1.22, p = 0.70). There was also no difference in the risk of infant stunting at 1 year of age between the vitamin D3 (407 events among 867 infants) and placebo groups (413 events among 873 infants) (relative risk 1.00, 95% CI 0.92 to 1.10, p = 0.95). In terms of adverse events, no cases of maternal hypercalcemia were identified. One hypersensitivity reaction to the trial supplements occurred for a pregnant woman in the placebo group. A limitation of our study is that our findings may not be generalizable to HIV-negative pregnant women or contexts where severe vitamin D deficiency is prevalent.
Conclusions: The trial findings do not support routine vitamin D supplementation for pregnant and lactating women living with HIV in Tanzania.
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Study recommends no routine supplemention - wonder why?
It was too little, too late to help pregnancy and infants
But, it did reduce deaths
Expect far more lives saved and good pregnancy outcomes if had used >6,000 IU daily
Vitamin D Life - HIV category
Pregnant women in HIV therapy adding Vitamin D had 3X fewer deaths - RCT April 2022
HIV treatment augmented by high-dose vitamin D, daily or weekly – Dec 2021
HIV therapy reduces Vitamin D levels, supplementation helps - Nov 2019
Use of Tenofovir disoproxil fumarate (Hepatitis-B, AIDS) requires more vitamin D – Sept 2018
Low vitamin D with HIV increases risk of infections – TB by 3.5X, CMV by 10.1X – Aug 2020
Cognitive problems 2X more likely if HIV and low vitamin D – June 2019
Vertebral fractures 9X more likely in HIV patients having low vitamin D – Dec 2017
Those with HIV who doubled their vitamin D levels reduced their chance of death by 47 percent – Oct 2013
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