Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health

Universidade Federal do Rio de Janeiro

Status: Unknown

Conditions: Infant Bone Growth; Lactation Bone Loss

Treatments: Dietary Supplement: Calcium plus vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01732328

CNPq (Other Grant/Funding Number)

CAAE 0002.0361.000-09

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

76 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Inactive pill (microcrystalline cellulose and corn starch) taken daily

Calcium plus vitamin D

Active Comparator group

Description:

600mg of calcium and 200 international units (IU) vitamin D taken daily

Treatment:

Dietary Supplement: Calcium plus vitamin D