Clinical trial NCT01732328: Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health
Official title: Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation Bone Loss
Infant Bone Growth
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2012-11-22
Enrollment: 76
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.


Eligibility criteria: Inclusion Criteria:

* 13-19 y old
* between 23 and 29 wk of gestation
* primiparous
* carrying single fetus
* intending to exclusively or predominantly breastfeed

Exclusion Criteria:

* chronic health problems
* smokers
* users of nutritional supplements, except iron supplements provided during standard prenatal care

Primary outcomes:
measure: Differences in maternal bone mass changes postpartum between supplemented and placebo groups
timeFrame: 2, 5 and 12 months postpartum
measure: Differences in fetal growth and infant bone mass between supplemented and placebo groups
timeFrame: 2nd and 3rd trimester gestation and 2 mo postpartum
Secondary outcomes:
measure: Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups
timeFrame: 2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum
measure: Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups
timeFrame: 2 months postpartum
measure: Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms
timeFrame: 2, 5 and 12 months postpartum
measure: Differences in infant body composition between supplemented and placebo groups
timeFrame: 2 months postpartum
measure: Differences in changes of maternal body composition postpartum between supplemented and placebo groups
timeFrame: 2, 5 and 12 months postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Estado do Rio de Janeiro, Brazil
name: Flavia F Bezerra, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro, Brazil
name: Carmen M Donangelo, PhD
role: STUDY_DIRECTOR
References:
citation: Diogenes ME, Bezerra FF, Rezende EP, Donangelo CM. Calcium Plus Vitamin D Supplementation During the Third Trimester of Pregnancy in Adolescents Accustomed to Low Calcium Diets Does Not Affect Infant Bone Mass at Early Lactation in a Randomized Controlled Trial. J Nutr. 2015 Jul;145(7):1515-23. doi: 10.3945/jn.114.208140. Epub 2015 May 27.
citation: Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Pinhal I, Donangelo CM. Effect of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers: a randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Jul;98(1):82-91. doi: 10.3945/ajcn.112.056275. Epub 2013 May 29.